AzTrials
AzTrials

Head and Neck CancerNCT04552587

The HEART Study (Healthy Eating and Recovery Together)

A study testing Heart APP in people with Head and Neck Cancer and Survivorship, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Heart APP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteUnited States
Study dates
4 Dec 2020to 10 Oct 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Medical University of South Carolina

    Charleston, South Carolina, 29425

Other trials in United States

About this study

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

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.

Read the detailed 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.

Being tested
Heart APP
Keywords
mHealth, Head and Neck Cancer, Survivorship, Caregiver
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Heart APPBehavioural

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

Study groups in NCT04552587
Study groupRoleWhat they receive
HEARTExperimentalPatients and caregivers will complete a HEART visit virtually or in person. The visit includes a needs assessment that generates a tailored care plan with messages, referrals and educational materials for discussion with a nurse. Caregivers will receive brief training about the HEART App and then use the App for 4 weeks with bi-weekly real-time prompts and feedback.
Receives: Behavioral: Heart APP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 week follow-up visit

  2. 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).

    Measured: 6 week follow up visit

  3. Intervention Reach

    Percentage of those recruited who completed baseline and 6 week follow up surveys and the intervention session.

    Measured: Baseline and 6 week follow up visit

Secondary outcomes (16)
  1. 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.

    Measured: 6 week follow up visit only (no baseline comparison)

  2. 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.

    Measured: Baseline and 6 week follow up visit

  3. 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.

    Measured: Baseline and 6 week follow-up visit

  4. 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.

    Measured: Baseline and 6 week follow-up visit

  5. 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.

    Measured: Baseline and 6 week follow-up visit

  6. 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.

    Measured: Baseline and 6 week follow-up visit

  7. 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.

    Measured: Baseline and 6 week follow-up visit

  8. 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.

    Measured: Baseline and 6 week follow up visit

  9. 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).

    Measured: 4 weeks during app use

  10. 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."

    Measured: 6 week follow up visit

  11. 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.

    Measured: 6 week follow up visit

  12. Process Monitoring Data

    Resources needed: Session length overall, length of nursing portion of session, length of app training- number of minutes

    Measured: After session completion

  13. 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))?"

    Measured: Baseline and 6 week follow up visit

  14. 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

    Measured: Baseline and 6 week follow up visit

  15. 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.

    Measured: Baseline and 6 week follow up visit

  16. 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.

    Measured: Baseline and 6 week follow up visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2020
  2. Study start4 Dec 2020
  3. Primary completion10 Oct 2021
  4. Study completion10 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04552587
Sponsor's protocol ID
0006621
Other IDs
R21CA215557-02
Status last verified
Jan 2023
First submitted
3 Sep 2020
Last updated
20 Jan 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Heart APP in people with Head and Neck Cancer and Survivorship, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Meeting Patient-Caregiver Session and Care Plan Acceptability Criteria (time frame: 6 week follow-up visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in