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

University of Arizona144 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

144

Conditions

Cancer

Interventions

Symptom Assessment and Health CoachingBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Arizona Cancer Center

Tucson, Arizona, United States

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: 12 weeks

Establish preliminary efficacy in diet adherence.

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

Time frame: 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.

Time frame: 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.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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