The HEART Study (Healthy Eating and Recovery Together)

Head and Neck Cancer Clinical Trial

Official title:

A Mobile-Support Program to Facilitate Nutritional Caregiving in Head and Neck Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04552587
• Other study ID #: 0006621
• Secondary ID: R21CA215557-02
• Status: Completed
• Phase: N/A
• Start date: December 4, 2020
• Est. completion date: October 10, 2021

Study information

• Verified date: January 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Head and neck cancer survivors and their primary caregivers (N=25 dyads) will be enrolled to pilot test a nutrition support system with a care planning clinic visit and a caregiver mobile App. Participants will be asked to complete baseline and 6-week follow-up surveys. The clinic session (offered in person or remotely) will include a needs assessment and a tailored care plan with information, educational materials and referrals about participants' symptoms, behaviors, social concerns and caregiving tasks. After the visit, the program will provide an App for caregivers with follow-up resources and mobile support for one month.

Description:

The long-term goal of this research is to improve physical, emotional and social post-treatment outcomes in head and neck cancer survivors and caregivers by implementing a nutrition-focused mobile-Support program to prepare and support caregivers after treatment.

Head and neck cancer survivors and their primary caregivers (N=25 dyads) will be recruited to a single-arm intervention study to evaluate the feasibility, acceptability and short-term effects of a nutrition-focused mobile support system. The intervention includes 1) a clinic visit (offered in-person or virtually) with a tablet-based needs assessment at the end of or after completing treatment which will generate 2) a tailored care plan with messages, educational materials and referrals mapped to survivor and caregiver-endorsed concerns and 3) a caregiver App with encouragement, reminders and tips delivered through messaging and peer videos. Participants will complete baseline and 6-week follow-up surveys.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 10, 2021
• Est. primary completion date: October 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Patient Inclusion Criteria:

• 18 years and older

• Patients with stage I-IVB HNC of the upper aerodigestive tract (including lip/oral cavity, nasopharynx, salivary gland, oropharynx, hypopharynx, paranasal sinus, and larynx cancers and cutaneous cancers of the head and neck region)

• In the last two weeks of treatment to 3 months following completion of primary treatment (i.e., any combination of surgery, chemotherapy and radiation therapy) within the past 3 months

• Experienced nutritional challenges at the end of treatment as assessed in a 6-item screener

Patient Exclusion Criteria:

• head and neck cancer patients who do not undergo treatment

• Patients who do not read or understand English

• Patients who are cognitively impaired and cannot complete interviews, as judged by the referring health care provider

• Patients who do not have a smartphone for use in the study

Caregiver Inclusion Criteria:

• 18 years and older

• Provide care for a loved one with stage I-IVB head and neck cancer who has completed treatment

Caregiver Exclusion Criteria:

• Caregivers who do not read or understand English

• Caregivers who are cognitively impaired and cannot complete interviews, as judged by the referring health care provider

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Nutrition Aspect of Cancer
• Survivorship

Intervention

Behavioral:
• Heart APP
The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Meeting Patient-Caregiver Session and Care Plan Acceptability Criteria	Investigator developed questionnaire investigating acceptability of session intervention and care plan. Items were rated on a 6-point descriptive scale from strongly disagree to strongly agree. Participants that meet criteria are those that chose moderately or strongly agree. Items included: Session made me feel prepared, care plan information was helpful emotionally, care plan was helpful practically, amount of information in care plan provided was appropriate, timing of session of session was appropriate.	6 week follow-up visit
Primary	Intervention Delivery/ Fidelity	Number of caregivers receiving all session content and delivery of the intervention as planned (intro to session, nurse care plan discussion, viewed nutritional support video, app training).	6 week follow up visit
Primary	Intervention Reach	Percentage of those recruited who completed baseline and 6 week follow up surveys and the intervention session.	Baseline and 6 week follow up visit
Secondary	Ease of Use/System Usability	System Usability Scale (SUS) - The SUS consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Scores range from 0-100, with higher scores indicating better usability.	6 week follow up visit only (no baseline comparison)
Secondary	Mean Score of Unmet Needs	30-item Cancer Survivors/Partners Unmet Needs instruments (CaSUN/ CaSPUN). Needs were endorsed on a yes/no basis, with a range of 0-30 total endorsed needs. A higher score indicates more endorsed needs. Average number of needs is reported.	Baseline and 6 week follow up visit
Secondary	PROMIS Depression- Short Form (SF) v1.0 Form 8A	PROMIS Depression- SF v1.0 form 8A is an 8-item Patient-Reported Outcomes Measure Information System (PROMIS) short-form instrument. Respondents are asked how often in the past 7 days they have experienced specific depression symptoms, using a 5-point ordinal rating scale of "Never," "Rarely," "Sometimes," "Often," and "Always" whereby a higher score indicates higher depression. Raw score totals are converted to an item response theory-based T-scores. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10 with a range of 38.2 to 81.3. Therefore, a person with a T-score of 40 is one SD below the mean. A decrease in change from baseline to 6 week followup indicates reduced depression.	Baseline and 6 week follow-up visit
Secondary	Mean Score of Survivorship Readiness/Caregiver Preparedness	The 11-item Preparing for Life As a New Survivor (PLANS) Knowledge Subscale, developed at the University of Michigan, is utilized to evaluate survivor and caregiver (1) knowledge of diagnosis, treatment and side effects, and (2) communication with the cancer team regarding diagnosis, treatment and side effects and 3) preparedness for what to expect over the next year. Items are rated on a 6-point scale where: strongly disagree=1, moderately disagree =2, slightly disagree=3, slightly agree= 4, moderately agree=5 and strongly agree=6. Items were averaged, with a range of 1-6 with higher scores indicating higher levels of agreement.	Baseline and 6 week follow-up visit
Secondary	Mean Score of Self-Efficacy	Based on the National Cancer Institute Follow-up Care Use Among Survivors (FOCUS) survey, two questions were asked: "How confident are you that you can get advice or information related to your/your loved one's cancer if you needed at this time?" and "How confident are you that you can (assist your loved one to) keep to the follow-up care schedule recommended by your doctors?" Participants rated items on a 5-point Likert scale where 0="Not at all confident" to 4= "Completely confident." Scores were averaged for each question, whereby higher scores indicated higher level of confidence. Change from baseline to 6 week follow up is also reported. Negative change indicates decline in self-efficacy.	Baseline and 6 week follow-up visit
Secondary	Mean Score of Dyadic Coping/ Dyadic Efficacy	Dyadic Coping was measured using a 5-item cancer-specific subscale version of the Dyadic Coping Inventory. Items are rated on a 5-point scale from 1 ("never") to 5 ("always"). Scores were averaged with a higher score indicating a better outcome. A decrease in change between baseline and 6 week followup visit indicates worsening outcome over time.; Dyadic Efficacy is an investigator developed 1-item question "How confident are you that you and your loved one can work together as a team to manage the cancer-related problems that come up?" Item was answered on a scale of 0 ("not at all confident") to 10 ("extremely confident"), with average score reported. A decrease in change between baseline and 6 week followup visit indicates worsening, where as an increase in change indicates improvement.	Baseline and 6 week follow-up visit
Secondary	Health-Related Quality-of-Life (PROMIS Scale v1.2 - Global Health)	PROMIS Scale v1.2 - Global Health short form consists of 10 items that assess overall perceived quality of life and five general domains of health and functioning including overall physical health, mental health, social health, pain, and fatigue. Scoring uses a 5-point Likert scale with the response scores reversed (5=None to 1=Very severe) so that higher scores for responses always indicate better health. Raw scores are summed and converted to a T-score (mean score of 50, SD ± 10), Therefore a person with a T-score of 40 is one SD below the mean. A decrease in the change from baseline to 6 week follow up indicates worsening quality of life, whereas an increase indicates improvement.	Baseline and 6 week follow-up visit
Secondary	Caregiver Burden	4-item screening version of the Zarit Burden Interview is a self-report measure of caregiver burden. Caregivers rate each item on a 5-point Likert scale (0=never, 4= nearly always). Higher scores indicate greater caregiver distress. Total score range: 0 to 16, = 8: high burden. An increase in change from baseline to 6 week follow up visit indicates increased caregiver distress.	Baseline and 6 week follow up visit
Secondary	Ease of Mobile App Use/User Engagement	Number of weekly prompt responses missed out of 184 total expected (23 caregivers given 2 prompts per week for 4 weeks).	4 weeks during app use
Secondary	Number of Participants With Care Plan Use Endpoints	Number of participants of use of care plan after session, including patient and caregiver report of "Referred to Care Plan again," "Used Care Plan," "Used educational materials," and "Shared Care Plan with others."	6 week follow up visit
Secondary	Percentage of Participants Rating App Satisfaction/ Perceived Importance	Ratings of satisfaction with app and prompts on a 6 point descriptive rating scale ranging from strongly agree to strongly disagree. Measurements reported below are count of participants who moderately or strongly agreed with individual prompts.	6 week follow up visit
Secondary	Process Monitoring Data	Resources needed: Session length overall, length of nursing portion of session, length of app training- number of minutes	After session completion
Secondary	Change From Baseline in Nutritional Status Scale	Investigator-developed 1 item: "During the past two weeks, how satisfied have you been with your nutritional status (from Extremely satisfied (1) to Not at all satisfied (5))?"	Baseline and 6 week follow up visit
Secondary	Change From Baseline in Symptom Distress/Symptom Management	Adapted Symptom Distress Scale 1 item scaled to assess how distressing symptoms are to participant. 0= not at all distressing, 10= extremely distressing; 1 item to assess patient and caregiver perceptions concerning patient ability to manage symptoms. 0= can manage extremely well, 10= cannot manage at all	Baseline and 6 week follow up visit
Secondary	Change From Baseline in Emotional Support	PROMIS Short Form v2.0 - Emotional Support - 4a is a 4-item questionnaire. Item banks (currently adults only) assess perceived feelings of being cared for and valued as a person; having confidant relationships. PROMIS instruments are scored using item-level calibrations. Each question usually has five response options ranging in value from one to five. Raw scores are the sum of values of the response to each question then rescaled to to a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean.	Baseline and 6 week follow up visit
Secondary	Change From Baseline in Symptom Severity	MD Anderson Symptom Inventory (MDASI) Head and Neck Module- Includes 13 core items and an additional 9 head and neck cancer module items which calculates a total score of symptom severity. The MDASI assesses the severity of symptoms at their worst in the last 24 hours on a 0-10 Numeric Rating Scale, with 0 being "not present" and 10 being "as bad as you can imagine." Core items and module symptom items are averaged into a mean module severity. A higher score always indicates an increase in severity. A decrease in change from baseline to 6 week follow up indicates improvement of symptoms.	Baseline and 6 week follow up visit