An Internet-based Program to Help Cancer Survivors Manage Pain

Cancer Clinical Trial

— IMPACTS  

Official title:

Internet-delivered Management of Pain Among Cancer Treatment Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04462302
• Other study ID #: IRB00066906
• Secondary ID: 3UG1CA189824-06S
• Status: Recruiting
• Phase: N/A
• Start date: May 13, 2021
• Est. completion date: April 1, 2025

Study information

• Verified date: February 2024
• Source: Wake Forest University Health Sciences
• Contact: Karen Craver
• Phone: 336-716-0891
• Email: NCORP[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine whether an Internet-based pain coping skills program plus enhanced usual care, compared to enhanced usual care alone, yields significant improvements in the co-primary outcomes of pain severity (as measured by the Brief Pain Inventory (BPI)) and pain interference (also measured by the BPI) from baseline to the post-intervention assessment for cancer survivors with persistent pain.

Description:

This is a parallel group randomized controlled, prospective study that examines the effect of an Internet-based pain coping skills program on pain severity and pain interference among adult cancer survivors experiencing persistent cancer-related pain. The study also explores the effects of an Internet-based pain coping skills program on opioid/analgesic medication use, health-related quality of life, pain management self-efficacy and various other factors relevant among populations with persistent pain (i.e., fatigue, sleep, emotional distress, positive affect, pain impact, perceived cognitive problems, and cognitive performance), as well as qualitative assessments of participants experiences with pain and the intervention. A total of 250 participants will be enrolled (125 per arm) and randomized into the internet program arm (plus enhanced usual care) or Enhanced Usual Care alone.

Each participant will be enrolled in the study for 9 months (from randomization at week 0 to the final follow-up assessment at week 34).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 456
• Est. completion date: April 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Must have a documented diagnosis of invasive cancer that has been treated with either single modality therapy or any combination of surgery, radiation, and chemotherapy/drug therapy (e.g. cytotoxic therapy, targeted therapy, immunotherapy, hormonal therapy, etc.). Patients with a cancer history of only superficial skin cancers or in situ malignancy are not eligible.

• May be either off all treatment OR actively receiving anticancer therapy in an adjuvant setting, maintenance setting, or for active cancer.

• Patients who currently undergoing anticancer therapy should not have any plans to change or adjust their treatment during the intervention period. This includes changing to another therapy or ending therapy entirely.

• Patients who are currently receiving anticancer therapy at the screening process must have been on current therapy for at least four weeks. Alternatively, if they are planning to discontinue therapy before enrolling, they must have been off therapy for four weeks prior to enrollment.

• A minimum of four weeks must have elapsed since the most recent MAJOR surgical intervention.

• A minimum of two weeks must have elapsed since the most recent MINOR surgical procedure (e.g., port placement).

• In addition, eligible patients must not have a planned surgical procedure or course of radiation therapy during the 3-month study intervention period (i.e., the three months leading up to primary outcome evaluation-timepoint.

• Patients who are no longer receiving anticancer therapy must be less than/equal to 5 years since the completion of their anticancer therapy (e.g., time since the last day of chemotherapy administration, time since last day of radiotherapy, etc.).

• Must have pain indicated by a score of = 4 on PROMIS Pain Intensity (1a) scale, using the Pain Eligibility Interview.

• Must have a score of "Most Days" or higher on the Graded Chronic Pain Scale Revised (Abbreviated) using the Pain Eligibility Interview.

• Patients do not have to be on analgesic medications of any kind in order to participate. If they are taking analgesics, they must be on a stable analgesic regimen (i.e., no changes to the prescribed analgesic regimen) over a period of at least 14 days prior to enrollment. Eligible patients should not have planned upward dose titration of their analgesics during the 3-month study intervention period (i.e., the three months leading up to primary outcome evaluation timepoint. Patients may elect to decrease their analgesic use during the study as per discussions with their provider. Unexpected dose adjustments including dose escalations as a result of unforeseen clinical need is allowed in all patients at all times during the study. Cannabis prescribed for medicinal purposes would qualify as an analgesic in this context.

• Must have pain of new onset or significantly exacerbated since the time of cancer diagnosis or initiation of cancer treatment

• Must be expected to be able to complete all study activities including the 22- and 34-week follow-up assessments according to the treating/referring clinician (e.g., treating clinician feels the patient is unlikely to develop progressive disease requiring additional active cancer therapy through the 6-month follow-up period).

• ECOG performance status of 0, 1, or 2.

• Age =18 years at the time of study entry

• Must be able to speak, read and understand English.

Exclusion Criteria:

• Has a disability that precludes completion of study activities (e.g., severe vision or hearing impairment, diagnosis of dementia or clinical evidence of severe cognitive impairment, diagnosis or clinical evidence of severe psychiatric disorder, or diagnosed drug or alcohol abuse disorder), as per patient report or documented in the medical record.

• Reports only preexisting pain conditions unrelated to cancer or cancer treatment (e.g., migraine or tension headache, arthritis, back disorders, bursitis/tendonitis, injuries, fibromyalgia).

• Has a known or suspected diagnosable substance use disorder or opioid overuse disorder (according to DSM-5 criteria), or is actively receiving treatment for a substance use disorder, as per patient report or documented in the medical record.

• Currently being prescribed buprenorphine or suboxone.

• Patients enrolled on hospice care or end-of-life palliative care are not eligible for enrollment. Patients whose local care network provides an opportunity for palliative (symptom management) or supportive care concurrent with active treatment following diagnosis (i.e. not solely as a palliative or end-of-life measure) are considered eligible for this study.

• Does not have reliable access to Internet or sufficient personal data plan, and is not willing to participate in the Tablet Lending Program provided for this study.

• Does not have a working email address.

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Internet-based pain coping skills program
The purpose of this study is to determine if an 8-session Internet-based pain management program can help you better manage your cancer-related pain.

Locations

Country	Name	City	State
United States	Hawaii Cancer Care - Savio	'Aiea	Hawaii
United States	Hawaii Cancer Care - Westridge	'Aiea	Hawaii
United States	Pali Momi Medical Center	'Aiea	Hawaii
United States	Trinity Health Saint Joseph Mercy Hospital Ann Arbor	Ann Arbor	Michigan
United States	Kaiser Permanente-Deer Valley Medical Center	Antioch	California
United States	Flaget Memorial Hospital	Bardstown	Kentucky
United States	Ochsner High Grove	Baton Rouge	Louisiana
United States	Carle BroMenn Outpatient Center	Bloomington	Illinois
United States	Illinois CancerCare-Bloomington	Bloomington	Illinois
United States	Saint Joseph's/Candler - Bluffton Campus	Bluffton	South Carolina
United States	Prisma Health Cancer Institute - Spartanburg	Boiling Springs	South Carolina
United States	Central Care Cancer Center - Bolivar	Bolivar	Missouri
United States	Trinity Health Medical Center - Brighton	Brighton	Michigan
United States	Illinois CancerCare-Canton	Canton	Illinois
United States	Trinity Health Medical Center - Canton	Canton	Michigan
United States	Physicians' Clinic of Iowa PC	Cedar Rapids	Iowa
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Chelsea Hospital	Chelsea	Michigan
United States	Northwestern University	Chicago	Illinois
United States	Marshfield Clinic-Chippewa Center	Chippewa Falls	Wisconsin
United States	The Mark H Zangmeister Center	Columbus	Ohio
United States	The Mark H Zangmeister Center	Columbus	Ohio
United States	Mercy Hospital	Coon Rapids	Minnesota
United States	Carle on Vermilion	Danville	Illinois
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Cancer Care Specialists of Illinois - Decatur	Decatur	Illinois
United States	Kaiser Permanente-Franklin	Denver	Colorado
United States	Broadlawns Medical Center	Des Moines	Iowa
United States	Medical Oncology and Hematology Associates-Des Moines	Des Moines	Iowa
United States	Mercy Medical Center - Des Moines	Des Moines	Iowa
United States	Kaiser Permanente Dublin	Dublin	California
United States	Prisma Health Cancer Institute - Easley	Easley	South Carolina
United States	Marshfield Medical Center-EC Cancer Center	Eau Claire	Wisconsin
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Genesee Cancer and Blood Disease Treatment Center	Flint	Michigan
United States	Genesee Hematology Oncology PC	Flint	Michigan
United States	Genesys Hurley Cancer Institute	Flint	Michigan
United States	Mercy Hospital Fort Smith	Fort Smith	Arkansas
United States	CentraState Medical Center	Freehold	New Jersey
United States	Kaiser Permanente-Fremont	Fremont	California
United States	Kaiser Permanente-Fresno	Fresno	California
United States	Illinois CancerCare-Galesburg	Galesburg	Illinois
United States	Tidelands Georgetown Memorial Hospital	Georgetown	South Carolina
United States	Peninsula Cancer Institute - Gloucester	Gloucester	Virginia
United States	Prisma Health Cancer Institute - Butternut	Greenville	South Carolina
United States	Prisma Health Cancer Institute - Eastside	Greenville	South Carolina
United States	Prisma Health Cancer Institute - Faris	Greenville	South Carolina
United States	Prisma Health Cancer Institute - Greer	Greer	South Carolina
United States	Hackettstown Medical Center	Hackettstown	New Jersey
United States	Geisinger Medical Center-Cancer Center Hazleton	Hazleton	Pennsylvania
United States	South Carolina Cancer Specialists PC	Hilton Head Island	South Carolina
United States	Hawaii Cancer Care Inc - Waterfront Plaza	Honolulu	Hawaii
United States	Kaiser Permanente Moanalua Medical Center	Honolulu	Hawaii
United States	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii
United States	Queen's Cancer Cenrer - POB I	Honolulu	Hawaii
United States	Queen's Cancer Center - Kuakini	Honolulu	Hawaii
United States	Queen's Medical Center	Honolulu	Hawaii
United States	Straub Clinic and Hospital	Honolulu	Hawaii
United States	Ochsner Medical Center Kenner	Kenner	Louisiana
United States	Marshfield Medical Center - Ladysmith	Ladysmith	Wisconsin
United States	Kaiser Permanente-Rock Creek	Lafayette	Colorado
United States	Geisinger Medical Oncology-Lewisburg	Lewisburg	Pennsylvania
United States	Saint Joseph Hospital East	Lexington	Kentucky
United States	Saint Joseph Radiation Oncology Resource Center	Lexington	Kentucky
United States	Trinity Health Saint Mary Mercy Livonia Hospital	Livonia	Michigan
United States	Saint Joseph London	London	Kentucky
United States	Kaiser Permanente-Lone Tree	Lone Tree	Colorado
United States	Saint John's Hospital - Healtheast	Maplewood	Minnesota
United States	Marshfield Medical Center-Marshfield	Marshfield	Wisconsin
United States	Carle Physician Group-Mattoon/Charleston	Mattoon	Illinois
United States	Abbott-Northwestern Hospital	Minneapolis	Minnesota
United States	Marshfield Medical Center - Minocqua	Minocqua	Wisconsin
United States	Kaiser Permanente-Modesto	Modesto	California
United States	Morristown Medical Center	Morristown	New Jersey
United States	Knox Community Hospital	Mount Vernon	Ohio
United States	Marshfield Medical Center - Neillsville	Neillsville	Wisconsin
United States	Saint Peter's University Hospital	New Brunswick	New Jersey
United States	Ochsner Medical Center Jefferson	New Orleans	Louisiana
United States	Peninsula Cancer Institute - Newport News	Newport News	Virginia
United States	Newton Medical Center	Newton	New Jersey
United States	Carle BroMenn Medical Center	Normal	Illinois
United States	Carle Cancer Institute Normal	Normal	Illinois
United States	Kaiser Permanente-Oakland	Oakland	California
United States	Illinois CancerCare-Ottawa Clinic	Ottawa	Illinois
United States	Illinois CancerCare-Pekin	Pekin	Illinois
United States	Illinois CancerCare-Peoria	Peoria	Illinois
United States	Illinois CancerCare-Peru	Peru	Illinois
United States	Chilton Medical Center	Pompton	New Jersey
United States	Trinity Health Saint Joseph Mercy Oakland Hospital	Pontiac	Michigan
United States	Southern Ohio Medical Center	Portsmouth	Ohio
United States	Geisinger Cancer Services-Pottsville	Pottsville	Pennsylvania
United States	Kaiser Permanente- Marshall Medical Offices	Redwood City	California
United States	Marshfield Medical Center-Rice Lake	Rice Lake	Wisconsin
United States	Kaiser Permanente-Richmond	Richmond	California
United States	VCU Massey Cancer Center at Stony Point	Richmond	Virginia
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia
United States	North Memorial Medical Health Center	Robbinsdale	Minnesota
United States	Kaiser Permanente-Roseville	Roseville	California
United States	Kaiser Permanente Downtown Commons	Sacramento	California
United States	Kaiser Permanente-South Sacramento	Sacramento	California
United States	Heartland Regional Medical Center	Saint Joseph	Missouri
United States	Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Minnesota
United States	Regions Hospital	Saint Paul	Minnesota
United States	United Hospital	Saint Paul	Minnesota
United States	Kaiser Permanente-San Francisco	San Francisco	California
United States	Kaiser Permanente-Santa Teresa-San Jose	San Jose	California
United States	Kaiser Permanente San Leandro	San Leandro	California
United States	Kaiser San Rafael-Gallinas	San Rafael	California
United States	Kaiser Permanente Medical Center - Santa Clara	Santa Clara	California
United States	Kaiser Permanente-Santa Rosa	Santa Rosa	California
United States	Lewis Cancer and Research Pavilion at Saint Joseph's/Candler	Savannah	Georgia
United States	Community Medical Center	Scranton	Pennsylvania
United States	Prisma Health Cancer Institute - Seneca	Seneca	South Carolina
United States	CHRISTUS Highland Medical Center	Shreveport	Louisiana
United States	VCU Community Memorial Health Center	South Hill	Virginia
United States	Kaiser Permanente-South San Francisco	South San Francisco	California
United States	Marshfield Medical Center-River Region at Stevens Point	Stevens Point	Wisconsin
United States	Lakeview Hospital	Stillwater	Minnesota
United States	Kaiser Permanente-Stockton	Stockton	California
United States	Overlook Medical Center	Summit	New Jersey
United States	Carle Cancer Center	Urbana	Illinois
United States	Kaiser Permanente Medical Center-Vacaville	Vacaville	California
United States	Kaiser Permanente-Vallejo	Vallejo	California
United States	Peninsula Cancer Institute - Cancer Specialists of Tidewater	Virginia Beach	Virginia
United States	Illinois CancerCare - Washington	Washington	Illinois
United States	Marshfield Clinic-Wausau Center	Wausau	Wisconsin
United States	Marshfield Medical Center - Weston	Weston	Wisconsin
United States	Geisinger Wyoming Valley/Henry Cancer Center	Wilkes-Barre	Pennsylvania
United States	Peninsula Cancer Institute - Williamsburg	Williamsburg	Virginia
United States	Rice Memorial Hospital	Willmar	Minnesota
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina
United States	Marshfield Clinic - Wisconsin Rapids Center	Wisconsin Rapids	Wisconsin
United States	Minnesota Oncology Hematology PA-Woodbury	Woodbury	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI), National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Severity	The Pain Severity via Brief Pain Inventory (BPI) subscale score is the mean of 4 items measuring current pain, pain on average, and pain at its worst and least in the past 7 days on a scale from 0 (no pain) to 10 (pain as bad as you can imagine).	Change from Baseline to 10 week
Primary	Pain Interference	The Pain Interference via Brief Pain Inventory (BPI) subscale score is the mean rating of 7 items measuring impact of pain on walking, work, mood, enjoyment of life, relations with others, sleep, general activity on a scale from 0 (does not interfere) to 10 (completely interferes).	Change from Baseline to 10 week
Secondary	Pain Severity	The Pain Severity via Brief Pain Inventory (BPI) subscale score is the mean of 4 items measuring current pain, pain on average, and pain at its worst and least in the past 7 days on a scale from 0 (no pain) to 10 (pain as bad as you can imagine).	22 and 34 weeks
Secondary	Pain Interference	The Pain Interference via Brief Pain Inventory (BPI) subscale score is the mean rating of 7 items measuring impact of pain on walking, work, mood, enjoyment of life, relations with others, sleep, general activity on a scale from 0 (does not interfere) to 10 (completely interferes).	22 and 34 weeks
Secondary	Opioid/analgesic medication use	A participant recall during clinic visits of typical daily medication use. This will be converted to morphine milligram equivalents (MME).	Baseline and 10 week
Secondary	Opioid/analgesic medication use	7-day medication diaries to capture participants' use of all medications each day during a 7-day period. Self-reports will be converted to morphine milligram equivalents (MME).	Baseline, 10, 22, and 24 week
Secondary	Health-Related Quality of Life	Health-Related Quality of Life will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (Short Form-6b). The six items are summed to give a score from 6 to 30, with higher scores representing better physical function.	Baseline, 10, 22, and 24 week
Secondary	Pain Management Self-Efficacy	Pain Management Self-Efficacy will be assessed with the Chronic Pain Self-Efficacy Scale. The self-efficacy for pain management subscale (PSE) consists of five items summed to give a score from 50-500, the self-efficacy for physical function subscale (FSE) consists of nine items summed to give a score from 90-900, and the self-efficacy for coping with symptoms subscale (CSE) consists of eight items summed to give a score from 80-800. For all subscales, higher scores represent greater self-efficacy.	Baseline, 10, 22, and 24 week