Improving Adherence to ACS Guidelines on Nutrition and Physical Activity in Latinas With Cancer and Their Informal Caregivers

NCT04314479 | Completed DMC

• 1 other identifier: 1801209654
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is testing the feasibility and acceptability of a 12-week intervention that integrates telephone coaching and printed materials about the ACS guidelines and healthy lifestyle behaviors in order to manage symptoms after treatment for cancer. We will recruit 57 dyads (the survivor plus one identified informal caregiver) from the community.

Conditions

Cancer

Keywords

Cancer; Cancer symptoms; Cancer survivors; Latina; Nutrition; Healthy lifestyle

Outcome Measures

Primary Outcomes (5)

• Determine the feasibility

  Feasibility assessed by consent rate of 50% and 2) completion rate of intervention of 80% Acceptability assessed by open-ended questions as part of exit interview/satisfaction survey at end of study (80% benchmark for dyads considering intervention helpful).

  12 weeks

• Determine acceptability

  Acceptability assessed by completion rate of intervention of 80%. Acceptability assessed by open-ended questions as part of exit interview/satisfaction survey at end of study (80% benchmark for dyads considering intervention helpful).

  12 weeks

• Establish preliminary efficacy in diet adherence.

  Preliminary efficacy for improvement assessed utilizing NCI Dietary Screener Questionnaire for diet.

  12 weeks

• Establish preliminary efficacy in physical activity adherence.

  Preliminary efficacy for improvement assessed utilizing Women's Health Initiative (WHI) Physical Activity Questionnaire for physical activity.

  12 weeks

• Establish preliminary efficacy via symptom improvement.

  Preliminary efficacy for improvement assessed utilizing General Symptom Distress Scale for symptoms/QoL and Patient Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy Short Form for self-efficacy for symptom management.

  12 weeks

Study Arms (2)

Symptom Assessment and Health Coaching

EXPERIMENTAL

The intervention condition will involve weekly symptom assessment and health coaching to manage symptoms and to meet the ACS cancer prevention guidelines provided over the telephone by trained health coaches. Participants will be completing the same forms/assessments throughout the study. The content will be built around the Symptom Management Toolkit. The coaching will be dictated by the symptoms the survivor or the support person is experiencing the week of the intervention call. All calls begin with the symptom assessments, only the intervention arm includes intervention coaching that focuses on physical activity, stress management, or eating a healthy diet to improve adherence to the ACS guidelines for cancer prevention. We anticipate coaching sessions will last approximately 20 - 45 minutes

Behavioral: Symptom Assessment and Health Coaching

Symptom Assessment Only

OTHER

For participants randomized to the control condition weekly symptom assessment telephone calls will be completed by staff at the University of Arizona Cancer Center Behavioral Measurements Interventions Shared Resource (BMISR). At week 13 an exit interview will be completed by the study coordinator to record participants feedback regarding study intervention, length, coaches, etc… In addition, staff from BMISR will call to repeat all baseline measures with the exception of the demographic questionnaires. Symptom assessment calls will take approximately 15 minutes.

Behavioral: Symptom Assessment and Health Coaching

Interventions

Symptom Assessment and Health Coaching BEHAVIORAL

The intervention condition will involve weekly symptom assessment and health coaching to manage symptoms and to meet the ACS cancer prevention guidelines provided over the telephone by trained health coaches. Participants will be completing the same forms/assessments throughout the study. The content will be built around the Symptom Management Toolkit. The coaching will be dictated by the symptoms the survivor or the support person is experiencing the week of the intervention call. All calls begin with the symptom assessments, only the intervention arm includes intervention coaching that focuses on physical activity, stress management, or eating a healthy diet to improve adherence to the ACS guidelines for cancer prevention. We anticipate coaching sessions will last approximately 20 - 45 minutes.

Symptom Assessment Only; Symptom Assessment and Health Coaching

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients must be female; caregiver may be male or female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients
• Female
• at least 18 years of age
• diagnosis of cancer
• speak and understand English or Spanish
• are finishing (or have finished) curative intent cancer treatment and do not have any subsequent cancer treatments planned, except for hormonal therapy or trastuzumab for breast cancer.
• Patients must also have at least 1 of the 5 most common cancer-related symptoms (pain, sleep disturbance, anxiety, depression and/or fatigue) with a severity score of 4 or higher (2 or higher for depression) on a 0-10 rating scale which is based on the National Comprehensive Cancer Network guidelines for symptom monitoring.
• Caregivers
• must be 18 years or older
• able to speak and understand English or Spanish
• not currently treated for cancer preserving the distinction between survivor and caregiver.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Tracy E. Crane, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 19, 2020
• Study Start: March 15, 2018
• Primary Completion: June 8, 2019
• Study Completion: June 16, 2019
• Last Updated: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)