Cancer Clinical Trial
Official title:
ActivityChoice: A Clinic-delivered Implementation Program to Increase Physical Activity and Decrease Cardiovascular Disease Risk Amongst Cancer Survivors
Verified date | October 2023 |
Source | University of Massachusetts, Worcester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Cardiovascular disease, the number one leading cause of death in the United States, is highly prevalent in cancer survivors. Physical activity can reduce risk, and referrals to programs addressing survivors' choices are highly recommended from providers in cancer survivorship, though rarely implemented. The study team proposes to develop ActivityChoice, a clinic-based implementation program, using patient narrative decision aids to support choices to a group in-person, group virtual, or self-monitored digital health physical activity program.
Status | Enrolling by invitation |
Enrollment | 114 |
Est. completion date | November 1, 2026 |
Est. primary completion date | August 1, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 110 Years |
Eligibility | AIM 1 Inclusion Criteria for Aim 1a 1. Prior cancer diagnosis 2. 18 years of age and older 3. Speaks English Exclusion Criteria for Aim 1a 1. No prior cancer diagnosis 2. Under 18 years of age 3. Prisoners 4. Does not speak English AIM1B Survivor Inclusion Criteria for Aim 1b 1. Prior cancer diagnosis 2. 18 years of age and older 3. Speaks English Survivor Exclusion Criteria for 1b 1. No prior cancer diagnosis 2. Under 18 years of age 3. Does not speak English 4. Prisoners 5. Participated in Aim 1a Clinic Staff Inclusion Criteria for Aim 1b 1. Provide cancer care for patients at one of the four UMass cancer clinics, 2. Involved in survivorship care planning visits 3. Speaks English 4. 18 years of age and older Clinic Staff Exclusion Criteria for 1b 1. Is not employed at one of the four UMass cancer clinics 2. Is not involved in survivorship care planning visits 3. Does not speak English 4. Prisoners 5. Under 18 years of age Pregnant Women Pregnant women may be included in this study as an incidental population. AIM 2 Clinic Staff Inclusion Criteria for Aim 2 1. Provide cancer care for patients at one of the four UMass cancer clinics 2. Involved in survivorship care visits 3. Speaks English 4. 18 years of age and older Clinic Staff Exclusion Criteria for Aim 2 1. Is not employed at one of the four UMass cancer clinics 2. Is not involved in survivorship care visits 3. Does not speak English 4. Prisoners 5. Under 18 years of age Survivor Inclusion Criteria for Aim 2 1. Cancer Patient at one of the four UMass cancer clinics 2. Has a survivorship care planning visit 3. Able to perform physical activity 4. Completes Physical Activity Readiness Questionnaire (PAR-Q) physical activity readiness questionnaire or has medical clearance to participate 5. Has a smartphone 6. Speaks English 7. 18 years of age and older Survivor Exclusion Criteria for Aim 2: 1. Not a cancer patient at one of the four UMass cancer clinics 2. Does not have a survivorship care planning visit 3. Unable to perform physical activity or no medical clearance to participate 4. Does not speak English 5. Under 18 years of age 6. Does not have a smartphone 7. Prisoners 8. Is pregnant AIM 3 Clinic Staff Inclusion Criteria for Aim 3 1. Are enrolled in ActivityChoice 2. = 18 years of age 3. Provide written informed consent Patient Inclusion Criteria for Aim 3 1. Are enrolled in ActivityChoice 2. Had a clinic visit with one of the enrolled clinic staff during the study period 3. = 18 years of age 4. Speaks English 5. Provide written informed consent Patient Exclusion Criteria for Aim 3 1. Not enrolled in ActivityChoice 2. Was not seen in the clinic by an enrolled clinic staff during the study period UMass Cancer Clinic Administration Inclusion Criteria for Aim 3 1. Are = 18 years of age 2. Are in positions of cancer center leadership 3. Provide written informed consent UMass Cancer Clinic Administration Exclusion Criteria for Aim 3 1. Unable or unwilling to provide written informed consent 2. Not in positions of leadership within the UMass Medical Cancer Clinic Administration 3. <18 years of age. External site stakeholders Inclusion Criteria for Aim 3 1. Are =18 years of age 2. Are in positions of cancer center leadership 3. Provide written informed consent. External site stakeholders Exclusion Criteria for Aim 3 1. Unable or unwilling to provide written informed consent 2. Not in positions of leadership overseeing cancer survivorship 3. <18 years of age. |
Country | Name | City | State |
---|---|---|---|
United States | University of Massachusetts Chan Medical School | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
University of Massachusetts, Worcester | National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Clinician, Patient, Leadership, and External Partner Acceptability | Semi-structured interviews using interview guides with enrolled clinicians, referred survivors, clinic leadership, and external partners | At study completion, within 3 months of enrollment | |
Primary | Proportion of patients referred as obtained by the electronic referral system and electronic health record | The number of patients referred/The number of eligible patients | Baseline | |
Secondary | Proportion of eligible clinicians enrolling in the the study | Number of enrolled clinicians/Number of eligible clinicians | Baseline | |
Secondary | Clinic/Clinician fidelity of delivering patient decision aids | Clinic delivery of patient decision aids as reported by patients | Baseline | |
Secondary | Patient Engagement | Program enrollment (number referred/number enrolled); | Examined at baseline, 3-, and 6-months | |
Secondary | Patient Retention | Percent of enrolled patients completing follow-up surveys at 3- and 6-months | 3- and 6-months | |
Secondary | Patient narrative decision aid acceptability and effectiveness (Enhanced Referral only) | Acceptability of decision aid using the Ottawa Decision Aid Centre 10-item acceptability of decision aids (Minimum score=0, Maximum score=100; Higher score indicates higher decisional conflict and uncertainty | Baseline following referrals | |
Secondary | Patient Autonomous Regulation | Behavioral Regulation for Exercise Questionnaire-2 (Minimum=0, Maximum=76; Higher scores indicates greater regulation/motivation) | Baseline, 3- and 6-months | |
Secondary | Patient Objective Physical Activity | Change from baseline to 3- and 6-months in steps, light, moderate and vigorous physical activity measured via Fitbits. | Baseline, 3- and 6-months | |
Secondary | Patient Self-Report Physical Activity | Change from baseline to 3- and 6-months in light, moderate and vigorous physical activity survey-measured (Godin leisure time questionnaire) physical activity. The questionnaire is a 4-item self-administered questionnaire with the first three questions seeking information on the number of times one engages in mild, moderate and strenuous leisure-time physical activity bouts of at least 15 min duration in a typical week. Scores can range from 0 to 98, with the higher score meaning a greater level of activity for that week. | Baseline, 3- and 6-months | |
Secondary | Patient Health-related Quality of Life | Functional Assessment of Cancer Therapy-General (FACT-G): Physical, social, emotional and functional well-being (Minimum=0, Maximum=127; Higher score means a higher quality of life) | Baseline, 3- and 6-months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05346796 -
Survivorship Plan HEalth REcord (SPHERE) Implementation Trial
|
N/A | |
Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Completed |
NCT04867850 -
Effect of Behavioral Nudges on Serious Illness Conversation Documentation
|
N/A | |
Enrolling by invitation |
NCT04086251 -
Remote Electronic Patient Monitoring in Oncology Patients
|
N/A | |
Completed |
NCT01285037 -
A Study of LY2801653 in Advanced Cancer
|
Phase 1 | |
Completed |
NCT00680992 -
Study of Denosumab in Subjects With Giant Cell Tumor of Bone
|
Phase 2 | |
Completed |
NCT00062842 -
Study of Irinotecan on a Weekly Schedule in Children
|
Phase 1 | |
Active, not recruiting |
NCT04548063 -
Consent Forms in Cancer Research: Examining the Effect of Length on Readability
|
N/A | |
Completed |
NCT04337203 -
Shared Healthcare Actions and Reflections Electronic Systems in Survivorship
|
N/A | |
Recruiting |
NCT04349293 -
Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways
|
N/A | |
Terminated |
NCT02866851 -
Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy
|
N/A | |
Active, not recruiting |
NCT05304988 -
Development and Validation of the EFT for Adolescents With Cancer
|
||
Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
Completed |
NCT00340522 -
Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
|
||
Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
Completed |
NCT03109041 -
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
|
Phase 1 | |
Terminated |
NCT01441115 -
ECI301 and Radiation for Advanced or Metastatic Cancer
|
Phase 1 | |
Recruiting |
NCT06206785 -
Resting Energy Expenditure in Palliative Cancer Patients
|