Advanced CancerBALANCENCT06796608
Behavioral Activation-Led Activity Engagement for Cancer Empowerment
A study testing Behavioral Activation in people with Advanced Cancer and Cancer, run by University of Pittsburgh at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Cancer
- What is being tested?
- Behavioral Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2025to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to read, write, or communicate in English
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Technology-Supported Behavioral Activation to Optimize Day-to-Day Quality of Life With Advanced Cancer
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?
Read more
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.
Read the detailed description
Participants (n=25) will be recruited from UPMC Hillman clinics.
Part 1 (Consent and Baseline data collection from weeks 1 to 4):
If eligible patients consent to participate, they will complete online baseline questionnaires. Participant's medical records will be reviewed to extract demographic information and clinical covariates, including information about their cancer, its treatment, biological variables such as sex and age, clinical variables such as comorbidities, surgeries and hospitalizations, medications, and other markers of health care utilization (e.g., emergency department visits). Once extracted, these values will be linked only to their study ID number.
At the initial visit (either in-person or online, 20-30 minutes), participants will also be oriented to the ecological momentary assessment procedures to assess self-reported daily quality of life and mood, activities, and experiences. Participants will install the BALANCE Android or iOS application on their smartphones. The participant ID will be entered into the app upon initial log in and will be saved locally on the device. Participants will have the opportunity to add additional activities to track for 2 days before the 4 weeks of Part 1 of the study begins. When participants receive the survey notification, it will open the application and they can proceed to take the survey in the BALANCE app on their smartphone. Participants will be asked to complete the EMA questions once each evening (approximately 5 minutes). Participants will be able to use the BALANCE app to access visualizations of their past survey responses and quality of life ratings along with activity and sleep data.
Participants will also be asked to wear a Fitbit device (Fitbit Inspire 3 or similar) for the duration of the study and to install the Fitbit app on their smartphone. The Fitbit is a wristwatch-sized waterproof device that assesses heart and breathing rates, physical activity, and sleep, skin temperature, and oxygen levels and wirelessly transmits data to the server. If they already own a Fitbit device, we will request access to their Fitbit data for the duration of their study participation.
Mid-Study Data Review (mid-study data review session following first 4 weeks of the study):
Participants will complete a mid-study data review session (in person or remotely, 20-30 minutes) with a member of our team during which they will be asked which activities, behaviors, and experiences they believe to be the most strongly related to their day-to-day quality of life. They will also be provided with the results of personalized analyses visualizing the factors most strongly correlated with their quality of life ratings over the past four weeks. Based on their own reflections and these personalized analyses, they will be asked to select at least 4 behaviors or activities to increase over the next four weeks. Participants will also complete a midpoint questionnaire at this time.
Part 2 (Data-based intervention from mid-study data review session to approximately 8 weeks):
For the second four weeks of the study, starting after the mid-study data review session with a study team member, participants will complete a morning survey to make a plan for behavior change, receive daily reminders to complete their planned activities through the BALANCE Android or iOS application on their smartphones, and will complete an evening survey to report their daily quality of life and indicate completed activities (both < 5 minutes) each day. Participants will also collect Fitbit data during the same period. At the end of this second 4-week period, we will invite participants for a 1-on-1 in-person or online semi-structured interview (20-30 minutes) to provide feedback. In addition, we will assist participants in removing the BALANCE app from their phones. Participants will also complete an end of study questionnaire at this time.
- Conditions
- Advanced Cancer, Cancer
- Being tested
- Behavioral Activation
- Keywords
- behavioral activation, quality of life
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral ActivationBehavioural
Also called Behavioral Intervention, Behavior Modification, Behavior or Life Style Modifications
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavioral Activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Post-intervention semi-structured interviews will be conducted to gather participant feedback and assess acceptability of the program
Measured: 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.
Measured: At the end of intervention at approximately 8 weeks
Feasibility
accrual rate (number of participants that enroll out of number of participants approached)
Measured: From enrollment to the end of intervention at approximately 8 weeks
Feasibility
completion rate (number of participants that complete the study)
Measured: 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)
Measured: From enrollment to the end of intervention at approximately 8 weeks
Secondary outcomes (3)
Daily ratings
Participants' average daily quality of life rating from 0 to 10 (with higher values indicating better days)
Measured: Change from baseline to the end of intervention at approximately 8 weeks
Quality of Life
Patient-Reported Outcome Measurement Information System (PROMIS) 29+2 is used to evaluate general health-related quality of life. The seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) have four items per domain and use a 5-point Likert response scale. Possible range of scores for these 7 domains is 4 to 20. The pain intensity item uses a numeric rating scale (0 [no pain] to 10 [worst pain imaginable]). The sum of raw scores for each domain is converted into a standardized T-score using a publicly available conversion table or an online scoring service. Higher scores represent worse symptoms for symptom-oriented domains (anxiety, depression, fatigue, pain intensity, pain interference, and sleep disturbance) and better health outcomes for function-oriented domains (physical functioning and ability to participate in social roles and activities).
Measured: Change from baseline to the end of intervention at approximately 8 weeks
Depressive symptoms
Center for Epidemiologic Studies Depression Scale (CES-D Scale). Possible range of scores is 0 to 60, with the higher scores indicating the presence of more symptomatology.
Measured: Change from baseline to the end of intervention at approximately 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start28 Jan 2025
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carissa Low, University of Pittsburgh
- Investigators
- Carissa A Low, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796608
- Sponsor's protocol ID
- STUDY24010177
- Acronym
- BALANCE
- Status last verified
- May 2025
- First submitted
- 18 Dec 2024
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Preliminary IPD data from this pilot study will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-Supported Behavioral Activation to Optimize Day-to-Day Quality of Life With Advanced Cancer
- ClinicalTrials.gov ID
- NCT06796608
- Acronym / sponsor ID
- BALANCE / STUDY24010177
- Conditions
- Advanced Cancer, Cancer
- Keywords
- behavioral activation, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants (n=25) will be recruited from UPMC Hillman clinics.
Part 1 (Consent and Baseline data collection from weeks 1 to 4):
If eligible patients consent to participate, they will complete online baseline questionnaires. Participant's medical records will be reviewed to extract demographic information and clinical covariates, including information about their cancer, its treatment, biological variables such as sex and age, clinical variables such as comorbidities, surgeries and hospitalizations, medications, and other markers of health care utilization (e.g., emergency department visits). Once extracted, these values will be linked only to their study ID number.
At the initial visit (either in-person or online, 20-30 minutes), participants will also be oriented to the ecological momentary assessment procedures to assess self-reported daily quality of life and mood, activities, and experiences. Participants will install the BALANCE Android or iOS application on their smartphones. The participant ID will be entered into the app upon initial log in and will be saved locally on the device. Participants will have the opportunity to add additional activities to track for 2 days before the 4 weeks of Part 1 of the study begins. When participants receive the survey notification, it will open the application and they can proceed to take the survey in the BALANCE app on their smartphone. Participants will be asked to complete the EMA questions once each evening (approximately 5 minutes). Participants will be able to use the BALANCE app to access visualizations of their past survey responses and quality of life ratings along with activity and sleep data.
Participants will also be asked to wear a Fitbit device (Fitbit Inspire 3 or similar) for the duration of the study and to install the Fitbit app on their smartphone. The Fitbit is a wristwatch-sized waterproof device that assesses heart and breathing rates, physical activity, and sleep, skin temperature, and oxygen levels and wirelessly transmits data to the server. If they already own a Fitbit device, we will request access to their Fitbit data for the duration of their study participation.
Mid-Study Data Review (mid-study data review session following first 4 weeks of the study):
Participants will complete a mid-study data review session (in person or remotely, 20-30 minutes) with a member of our team during which they will be asked which activities, behaviors, and experiences they believe to be the most strongly related to their day-to-day quality of life. They will also be provided with the results of personalized analyses visualizing the factors most strongly correlated with their quality of life ratings over the past four weeks. Based on their own reflections and these personalized analyses, they will be asked to select at least 4 behaviors or activities to increase over the next four weeks. Participants will also complete a midpoint questionnaire at this time.
Part 2 (Data-based intervention from mid-study data review session to approximately 8 weeks):
For the second four weeks of the study, starting after the mid-study data review session with a study team member, participants will complete a morning survey to make a plan for behavior change, receive daily reminders to complete their planned activities through the BALANCE Android or iOS application on their smartphones, and will complete an evening survey to report their daily quality of life and indicate completed activities (both < 5 minutes) each day. Participants will also collect Fitbit data during the same period. At the end of this second 4-week period, we will invite participants for a 1-on-1 in-person or online semi-structured interview (20-30 minutes) to provide feedback. In addition, we will assist participants in removing the BALANCE app from their phones. Participants will also complete an end of study questionnaire at this time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Activity tracking via smartphone app | Experimental | Behavioral: Behavioral ActivationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Unable to read, write, or communicate in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral ActivationAlso: Behavioral Intervention, Behavior Modification, Behavior or Life Style ModificationsBehavioral 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. | Behavioural | Activity tracking via smartphone app |
Primary outcome
Acceptability
Time frame: At end of intervention at approximately 8 weeks
Post-intervention semi-structured interviews will be conducted to gather participant feedback and assess acceptability of the program
Acceptability
Time frame: At the end of intervention at approximately 8 weeks
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.
Feasibility
Time frame: From enrollment to the end of intervention at approximately 8 weeks
accrual rate (number of participants that enroll out of number of participants approached)
Feasibility
Time frame: From enrollment to the end of intervention at approximately 8 weeks
completion rate (number of participants that complete the study)
Feasibility
Time frame: From enrollment to the end of intervention at approximately 8 weeks
engagement (how many days within the study the participants engaged with the app and had Fitbit data)
3 secondary outcomes
Daily ratings
Time frame: Change from baseline to the end of intervention at approximately 8 weeks
Quality of Life
Time frame: Change from baseline to the end of intervention at approximately 8 weeks
Depressive symptoms
Time frame: Change from baseline to the end of intervention at approximately 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: No. Preliminary IPD data from this pilot study will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carissa A Low, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation in people with Advanced Cancer and Cancer, run by University of Pittsburgh 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?
The sponsor lists 2 inclusion and 1 exclusion criteria. 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 7 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acceptability (time frame: At end of intervention at approximately 8 weeks). The study lists 5 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 7 May 2025.