Behavioral Activation-Led Activity Engagement for Cancer Empowerment

NCT06796608 | Completed

• 1 other identifier: STUDY24010177
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to learn if behavioral activation can improve daily quality of life for patients with advanced cancer. The main questions it aims to answer are:

• Can behavioral activation be adapted to help patients living with advanced cancer optimize their daily quality of life?
• Can behavioral activation be delivered primarily via smartphone? Participants will:
• Complete a demographic questionnaire at the beginning of the study and quality-of-life and activity questionnaires at the beginning, midpoint, and end of study. Complete nightly surveys about daily quality of life, mood, activities, and experiences.
• Wear a Fitbit activity tracker for 8 weeks.
• After the first four weeks, they will complete a session with a member of our team about their day-to-day activities, behaviors, and experiences. They will select at least 4 activities/behaviors to increase over the next portion of the study.
• Incorporate personalized meaningful activities into daily life
• At the end of approximately eight weeks, (four weeks after the session with a study team member), they will complete a semi-structured interview.

Conditions

Advanced Cancer; Cancer

Keywords

behavioral activation; quality of life

Outcome Measures

Primary Outcomes (5)

• Acceptability

  Post-intervention semi-structured interviews will be conducted to gather participant feedback and assess acceptability of the program

  At end of intervention at approximately 8 weeks

• Acceptability

  System Usability Scale (SUS). For odd items, subtract one from the user response. For even-numbered items, subtract the user responses from 5. This scales all values from 0 to 4 (with four being the most positive response). Add up the converted responses for each user and multiply that total by 2.5. Possible range of scores is 0 to 100 representing a composite measure of the overall usability of the system being studied.

  At the end of intervention at approximately 8 weeks

• Feasibility

  accrual rate (number of participants that enroll out of number of participants approached)

  From enrollment to the end of intervention at approximately 8 weeks

• Feasibility

  completion rate (number of participants that complete the study)

  From enrollment to the end of intervention at approximately 8 weeks

• Feasibility

  engagement (how many days within the study the participants engaged with the app and had Fitbit data)

  From enrollment to the end of intervention at approximately 8 weeks

Secondary Outcomes (3)

• Daily ratings

  Change from baseline to the end of intervention at approximately 8 weeks

• Quality of Life

  Change from baseline to the end of intervention at approximately 8 weeks

• Depressive symptoms

  Change from baseline to the end of intervention at approximately 8 weeks

Other Outcomes (3)

• Restorative Activities

  Change from baseline to the end of intervention at approximately 8 weeks

• Objective physical activity

  Change from baseline to the end of intervention at approximately 8 weeks

• Activity disruption

  Change from baseline to the end of intervention at approximately 8 weeks

Study Arms (1)

Activity tracking via smartphone app

EXPERIMENTAL

Participants will rate their day and indicate activities they did that day via the smartphone once each evening for the first four weeks. After four weeks, they will complete a mid-study data review session with a study team member about the activities, behaviors, and experiences they believe are most strongly related to their day-to-day quality of life. For the last 4 weeks of the study, they will select at least 4 behaviors or activities to increase. Participants will fill out morning surveys to plan an activity, receive daily reminders through the BALANCE app to support behavior change, and complete evening surveys to report daily quality of life and indicate completed activities.

Behavioral: Behavioral Activation

Interventions

Behavioral Activation BEHAVIORAL

Behavioral activation is an evidence-based intervention based on the idea that depression leads to withdrawal from rewarding activities, which sustains or exacerbates depression, and breaks this cycle by increasing the frequency with which people engage in rewarding activities regardless of their motivation. Like those with depression, people living with advanced cancer may reduce or stop participation in meaningful life activities resulting in decreased positive emotion and worse quality of life. The goal of this intervention is to adapt and test a fully remote technology-supported behavioral activation intervention aimed at supporting patients with advanced cancer to optimize the quality of their remaining years of life.

Also known as: Behavioral Intervention, Behavior Modification, Behavior or Life Style Modifications

Activity tracking via smartphone app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with Stage IV cancer and receiving ongoing treatment at a UPMC Hillman Cancer Center clinic
• owns and uses a smartphone capable of running study applications

You may not qualify if:

• Unable to read, write, or communicate in English

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Behavior Therapy

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Carissa A Low, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: January 28, 2025
• Study Start: January 28, 2025
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)