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

Improving Adherence to American Cancer Society (ACS) Guidelines on Nutrition and Physical Activity Through Integrated Symptom Management in Latinas With Cancer and Their Informal Caregivers

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Symptom Assessment and Health Coaching

Detailed Description

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. The study population is 36 Latinas who have recently completed treatment for solid tumor cancers and their informal caregiver (36 dyads). Research suggests that family members can be facilitators to behavior change more specifically, Latinos rely on family support more than non-Hispanic Whites.

Fewer than 20% of Latina cancer survivors meet the American Cancer Society's (ACS) Guidelines on Nutrition and Physical Activity. Healthier lifestyle behaviors (such as diet and physical activity) would result in an immediate benefit of reduced symptoms and long-term benefit of improved health while lowering cancer risk. This pilot study tests an intervention that will help in lessening survivors' symptoms to improve adherence to the ACS guidelines for cancer prevention ultimately improving overall health. A telephone-based intervention does not require any in-person meetings (outside of initial recruitment) and lessens participant burden.

The Specific Aims of this project are to evaluate this intervention among 36 survivors who have recently completed treatment for solid tumor cancers and their informal caregivers to 1) Determine the feasibility and acceptability of the intervention 2) Establish the preliminary efficacy for improvement in diet, physical activity, and quality of life for the dyads, and symptom burden for survivors through surveys given at baseline and study completion as well as a weekly symptom distress survey.

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Symptom Assessment and Health Coaching; 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; 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.
Other: Symptom Assessment Only; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Arizona
• Investigators: Principal Investigator: Tracy E. Crane, PhD, University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2018
• Primary Completion (Actual): June 8, 2019
• Study Completion (Actual): June 16, 2019

Study Registration Dates

• First Submitted: March 16, 2020
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (Actual): March 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Cancer; Nutrition; Healthy lifestyle; Cancer survivors; Cancer symptoms; Latina
• Other Study ID Numbers: 1801209654

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No