Prostate CancerNCT06461416
A Trial for a Preliminary Estimate of the Effectiveness of a Novel Theoretical Framework
A study testing ActiveHeal in people with Prostate Cancer and Breast Cancer, run by University of Arkansas at 1 site in United States.
Trial summary
Aim 1: To determine the preliminary effect sizes of al ActiveHeal EST (Engage-Sustain-Triumph) Program on occupational resilience. Aim 2: To determine the preliminary effect sizes of ActiveHeal EST (Engage-Sustain-Triumph) on health status [quality of life (QoL) and Psychological wellbeing (PWB)]. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Prostate Cancer, Breast Cancer
- What is being tested?
- ActiveHeal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2024to 30 Jun 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be an adult, diagnosed within the last 12 months with prostate or breast cancer and have had treatment(s) that may be ongoing or completed.
- Must be 18-75 years old.
- Must score 80 to 90 on the Karnofsky Performance Status Scale (KPSS) Exclusion Criteria
- Unable to use or lacking access to Teams (internet) and telephone during the study period.
- Unable or unwilling to participate in activity-based interventions.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Science
Fayetteville, Arkansas, 72203
About this study
Official title: Occupational Resilience: A Pilot Trial for a Preliminary Estimate of the Effectiveness of a Novel Theoretical Framework
- Aim 1: To determine the preliminary effect sizes of al ActiveHeal EST (Engage-Sustain-Triumph) Program on occupational resilience.
- Aim 2: To determine the preliminary effect sizes of ActiveHeal EST (Engage-Sustain-Triumph) on health status [quality of life (QoL) and Psychological wellbeing (PWB)].
- Aim 3: To determine the extent to which ActiveHeal EST (Engage-Sustain-Triumph) Program is an acceptable and feasible Intervention for breast and prostate cancer survivors.
Read the detailed description
The study will utilize the randomized study design with two groups of 15 participants each arm. The intervention group will receive occupational therapy services for 12 weeks. The control group will meet three times via zoom but not receive an intervention. All participants will have three assessments completed before and after the intervention. The experimental group will have a feasibility and acceptability survey at the end of the intervention.
Week 1-6 Recruitment, Informed Consent Process Commenced, and Randomization (Both Groups A \& B) Week 7-8 Pretests: Administer Occupational Resilience Measure (ORM 1.0), World Health Organization Quality of Life Scale (WHOQOL BREF), and Psychological Wellbeing Scale. To be completed with participant via Zoom (Both Groups A \& B) Week 9, 11, 15, \&18 (Week 1, 2, 3, 4, 7, \& 10 of the ActiveHeal EST (Engage-Sustain-Triumph)Program) Six Group ActiveHeal EST Sessions (Group A only). Each session is 75 minutes. It will include education on benefits of activity and strategies to make sustained performance possible (e.g., managing fatigue, pain, and edema), highlighting History, Experience, Benefits, and Adaptation (Location: Teams- Online). The group sessions will be led by the PI (or one of the trained occupational therapists who are familiar with the applied group and individual therapy process) and a student assistant to assist in the specified group activity performance. Although the intervention approach is specific, the use of activity as intervention is well understood by any certified occupational therapist. The training will therefore focus on what the sessions look like if these four factors are the guide to group or individual intervention, and a review of occupational therapy best practices for adults with cancer. Three additional therapists will be trained by PI in a 60 minute group session, to be able lead individual or group sessions.
Participants in the A group will receive exercise materials and handouts, a TENS unit and other resources for the individualized intervention plan. A Transcutaneous Electrical Nerve Stimulation (TENS) unit is a device that is included to help with pain control because pain often limits activity performance for cancer patients. It is not used to collect additional data but for pain control, to improve activity performance only for participants who report pain as a barrier in everyday tasks. All participants who receive the device will receive individualized education on how to use the device (during individual sessions). No information will be shared with the device manufacturer. Participants will be allowed to keep the devices to continue using it for pain control after the study. An example of an DFA-approved TENS unit is the TENS 7000 (www.tens7000.com).
ActiveHeal EST (Engage-Sustain-Triumph) group sessions will utilize a developmental group intervention model. Such intervention models allow the group to increasingly take charge of group activities and processes, with more structure and support at the beginning but members gradually take over leadership and group management roles, ideally running the group and meeting shared goals without a therapist by the end of the process . This model is selected because it has potential to enable members to develop relationships and build capacities that allow them to support one another after the intervention period. The model is also selected to allow participants to draw from benefits of group interventions, including installation of hope, universality, imparting of knowledge, altruism, corrective family re-enactment, development of socialization skills, imitative behavior, interpersonal learning, group cohesiveness, catharsis, and finding meaning.
Because these models are known to be optimal with 5-10 participants, Group A participants will be divided into two groups, but the same session plan will be used on the day of the meetings. That is, there will be two similar sessions per day of meeting, and participants will attend one session, with the same group each time. Group members will vote for their preferred activities for the upcoming meeting and the activities that are favored by the majority will be selected if consistent with group goals. These activities may include group physical exercise, healthy meal preparation activity, meditation, yoga, guided imagery, music experience (listening and/or performance) and dance.
All ActiveHeal EST (Engage-Sustain-Triumph) sessions will follow Cole's 7 steps, which are: Introduction, Activity, Sharing, Processing, Generalizing, Application, and Summary. These 7 steps will allow participants contemplate and share their experiences with a particular activity [History], demonstrate or build capacity for activity performance [Experience], reflect on health benefits of an activity [Benefits] and consider ways to sustain activity when barriers emerge []adaptation]. The 7 steps ensure that in each session group members will 1) evaluate the strategies they are using to enhance activity performance, 2) reflect or share how they have or could apply new strategies to support activity performance and health, and 3) develop an updated feasible plan of action while keeping in mind possible barriers and potential solutions to optimize activity engagement.
Each ActiveHeal EST (Engage-Sustain-Triumph) session will include a blend of 1) educational content and 2) shared activity to facilitate learning. Tentatively, the session themes include:
Optimizing lifestyle balance to improve health Psychoeducation, coping skills, relaxation Meditation/Mindfulness, yoga, creative arts Physical exercises, walking, hiking, aerobic activities Cognitive retraining Repeat of any of the above themes, based on what participants choose
Session themes about content will be retained regardless of the kind of activities selected by group members, but the sequence of themes will be determined in consultation with group members, consistent with commonly accepted group intervention guidelines.
Educational content will consistently highlight the impact of History, Experience, Benefits and Adaptation on long-term activity performance, and strategies for promoting success in enduring activity performance. Regardless of the session theme, four OR factors will be covered within Cole's last 3 steps, led by an occupational therapist and an assistant.
Week 11 \& 14 (Week 3 and 6 of active study period) Control Group B Meeting via Zoom - this study meeting lasts 15 to 30 minutes allowing the PI to touch base with the control participants to see how they are doing. This meeting is not intended to be therapeutic or interventional.
Week 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, \& 21 (Weekly Teams or Phone visit 12 week ActiveHeal EST (Engage-Sustain-Triumph) Program) Twelve Individualized ActiveHeal EST (Engage-Sustain-Triumph) Sessions (Group A only): Each participant in the experiment group will receive 12 occupational therapy Teams or phone calls. This session will focus on the activities that the participants selected at the start of the program. Using the methods covered in group sessions with individualized occupational therapy intervention added. All interventions will focus on building History, Experience, Benefits, and Adaptation to optimize activity performance. More focus may be given to any of the four, based on a participant's strengths and weaknesses, at the discretion of treating therapist. All four factors must be addressed and documented per visit, and justification will be provided if a factor is not addressed (for example when a participant does not show difficulty in that domain).
Week 17 (Week 9 of active study period) Control Group B Meeting via Zoom - this study meeting lasts 15 to 30 minutes allowing the PI to touch base with the control participants to see how they are doing. This meeting is not intended to be therapeutic or interventional.
Week 22-23 Posttests - (Re-administer Occupational Resilience Measure (ORM 1.0), World Health Organization Quality of Life Scale (WHOQOL BREF), and Psychological Wellbeing Scale. To be completed with participant via Zoom. (Both Groups A \& B). Group A will additionally complete Acceptability of Intervention Measure (AIM) and Feasibility of Intervention Measure (FIM).
- Conditions
- Prostate Cancer, Breast Cancer
- Being tested
- ActiveHeal
- Medical subject headings
- Prostatic Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiveHealBehavioural
Participants will have 6 group activity sessions and six individualized sessions from home, all focused on optimizing persistence in performance of specific selected activities.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Group A will receive telehealth occupational therapy services for 12 weeks Receives: Behavioral: ActiveHeal |
| Control | No intervention | Group B will meet three times via zoom but not receive an intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occupational Resilience Measure (ORM 1.0)
The ability to persist in selected daily activity despite challenges
Measured: Week 7-8; Week 22-23
Secondary outcomes (2)
World Health Organization Quality of Life Scale (WHOQOL-BREF)
Overall quality of life
Measured: Week 7-8; Week 22-23
Psychological Wellbeing Scale
Wellbeing
Measured: Week 7-8; Week 22-23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start10 Jun 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will utilize the randomized study design with two groups of 15 participants in each arm. The intervention group will receive telehealth occupational therapy services for 12 weeks. The control group will meet three times via zoom but not receive an intervention. All participants will have three assessments completed before and after the intervention.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461416
- Sponsor's protocol ID
- 276865
- Status last verified
- Dec 2024
- First submitted
- 10 Jun 2024
- Last updated
- 10 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Resilience: A Pilot Trial for a Preliminary Estimate of the Effectiveness of a Novel Theoretical Framework
- ClinicalTrials.gov ID
- NCT06461416
- Acronym / sponsor ID
- 276865
- Conditions
- Prostate Cancer, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 17 Jun 2024 (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.
- Aim 1: To determine the preliminary effect sizes of al ActiveHeal EST (Engage-Sustain-Triumph) Program on occupational resilience.
- Aim 2: To determine the preliminary effect sizes of ActiveHeal EST (Engage-Sustain-Triumph) on health status [quality of life (QoL) and Psychological wellbeing (PWB)].
- Aim 3: To determine the extent to which ActiveHeal EST (Engage-Sustain-Triumph) Program is an acceptable and feasible Intervention for breast and prostate cancer survivors.
Detailed description
The study will utilize the randomized study design with two groups of 15 participants each arm. The intervention group will receive occupational therapy services for 12 weeks. The control group will meet three times via zoom but not receive an intervention. All participants will have three assessments completed before and after the intervention. The experimental group will have a feasibility and acceptability survey at the end of the intervention.
Week 1-6 Recruitment, Informed Consent Process Commenced, and Randomization (Both Groups A \& B) Week 7-8 Pretests: Administer Occupational Resilience Measure (ORM 1.0), World Health Organization Quality of Life Scale (WHOQOL BREF), and Psychological Wellbeing Scale. To be completed with participant via Zoom (Both Groups A \& B) Week 9, 11, 15, \&18 (Week 1, 2, 3, 4, 7, \& 10 of the ActiveHeal EST (Engage-Sustain-Triumph)Program) Six Group ActiveHeal EST Sessions (Group A only). Each session is 75 minutes. It will include education on benefits of activity and strategies to make sustained performance possible (e.g., managing fatigue, pain, and edema), highlighting History, Experience, Benefits, and Adaptation (Location: Teams- Online). The group sessions will be led by the PI (or one of the trained occupational therapists who are familiar with the applied group and individual therapy process) and a student assistant to assist in the specified group activity performance. Although the intervention approach is specific, the use of activity as intervention is well understood by any certified occupational therapist. The training will therefore focus on what the sessions look like if these four factors are the guide to group or individual intervention, and a review of occupational therapy best practices for adults with cancer. Three additional therapists will be trained by PI in a 60 minute group session, to be able lead individual or group sessions.
Participants in the A group will receive exercise materials and handouts, a TENS unit and other resources for the individualized intervention plan. A Transcutaneous Electrical Nerve Stimulation (TENS) unit is a device that is included to help with pain control because pain often limits activity performance for cancer patients. It is not used to collect additional data but for pain control, to improve activity performance only for participants who report pain as a barrier in everyday tasks. All participants who receive the device will receive individualized education on how to use the device (during individual sessions). No information will be shared with the device manufacturer. Participants will be allowed to keep the devices to continue using it for pain control after the study. An example of an DFA-approved TENS unit is the TENS 7000 (www.tens7000.com).
ActiveHeal EST (Engage-Sustain-Triumph) group sessions will utilize a developmental group intervention model. Such intervention models allow the group to increasingly take charge of group activities and processes, with more structure and support at the beginning but members gradually take over leadership and group management roles, ideally running the group and meeting shared goals without a therapist by the end of the process . This model is selected because it has potential to enable members to develop relationships and build capacities that allow them to support one another after the intervention period. The model is also selected to allow participants to draw from benefits of group interventions, including installation of hope, universality, imparting of knowledge, altruism, corrective family re-enactment, development of socialization skills, imitative behavior, interpersonal learning, group cohesiveness, catharsis, and finding meaning.
Because these models are known to be optimal with 5-10 participants, Group A participants will be divided into two groups, but the same session plan will be used on the day of the meetings. That is, there will be two similar sessions per day of meeting, and participants will attend one session, with the same group each time. Group members will vote for their preferred activities for the upcoming meeting and the activities that are favored by the majority will be selected if consistent with group goals. These activities may include group physical exercise, healthy meal preparation activity, meditation, yoga, guided imagery, music experience (listening and/or performance) and dance.
All ActiveHeal EST (Engage-Sustain-Triumph) sessions will follow Cole's 7 steps, which are: Introduction, Activity, Sharing, Processing, Generalizing, Application, and Summary. These 7 steps will allow participants contemplate and share their experiences with a particular activity [History], demonstrate or build capacity for activity performance [Experience], reflect on health benefits of an activity [Benefits] and consider ways to sustain activity when barriers emerge []adaptation]. The 7 steps ensure that in each session group members will 1) evaluate the strategies they are using to enhance activity performance, 2) reflect or share how they have or could apply new strategies to support activity performance and health, and 3) develop an updated feasible plan of action while keeping in mind possible barriers and potential solutions to optimize activity engagement.
Each ActiveHeal EST (Engage-Sustain-Triumph) session will include a blend of 1) educational content and 2) shared activity to facilitate learning. Tentatively, the session themes include:
Optimizing lifestyle balance to improve health Psychoeducation, coping skills, relaxation Meditation/Mindfulness, yoga, creative arts Physical exercises, walking, hiking, aerobic activities Cognitive retraining Repeat of any of the above themes, based on what participants choose
Session themes about content will be retained regardless of the kind of activities selected by group members, but the sequence of themes will be determined in consultation with group members, consistent with commonly accepted group intervention guidelines.
Educational content will consistently highlight the impact of History, Experience, Benefits and Adaptation on long-term activity performance, and strategies for promoting success in enduring activity performance. Regardless of the session theme, four OR factors will be covered within Cole's last 3 steps, led by an occupational therapist and an assistant.
Week 11 \& 14 (Week 3 and 6 of active study period) Control Group B Meeting via Zoom - this study meeting lasts 15 to 30 minutes allowing the PI to touch base with the control participants to see how they are doing. This meeting is not intended to be therapeutic or interventional.
Week 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, \& 21 (Weekly Teams or Phone visit 12 week ActiveHeal EST (Engage-Sustain-Triumph) Program) Twelve Individualized ActiveHeal EST (Engage-Sustain-Triumph) Sessions (Group A only): Each participant in the experiment group will receive 12 occupational therapy Teams or phone calls. This session will focus on the activities that the participants selected at the start of the program. Using the methods covered in group sessions with individualized occupational therapy intervention added. All interventions will focus on building History, Experience, Benefits, and Adaptation to optimize activity performance. More focus may be given to any of the four, based on a participant's strengths and weaknesses, at the discretion of treating therapist. All four factors must be addressed and documented per visit, and justification will be provided if a factor is not addressed (for example when a participant does not show difficulty in that domain).
Week 17 (Week 9 of active study period) Control Group B Meeting via Zoom - this study meeting lasts 15 to 30 minutes allowing the PI to touch base with the control participants to see how they are doing. This meeting is not intended to be therapeutic or interventional.
Week 22-23 Posttests - (Re-administer Occupational Resilience Measure (ORM 1.0), World Health Organization Quality of Life Scale (WHOQOL BREF), and Psychological Wellbeing Scale. To be completed with participant via Zoom. (Both Groups A \& B). Group A will additionally complete Acceptability of Intervention Measure (AIM) and Feasibility of Intervention Measure (FIM).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will utilize the randomized study design with two groups of 15 participants in each arm. The intervention group will receive telehealth occupational therapy services for 12 weeks. The control group will meet three times via zoom but not receive an intervention. All participants will have three assessments completed before and after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: ActiveHealGroup A will receive telehealth occupational therapy services for 12 weeks |
| Control | No intervention | –Group B will meet three times via zoom but not receive an intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be an adult, diagnosed within the last 12 months with prostate or breast cancer and have had treatment(s) that may be ongoing or completed.
- Must be 18-75 years old.
- Must score 80 to 90 on the Karnofsky Performance Status Scale (KPSS) Exclusion Criteria
- Unable to use or lacking access to Teams (internet) and telephone during the study period.
- Unable or unwilling to participate in activity-based interventions.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ActiveHealParticipants will have 6 group activity sessions and six individualized sessions from home, all focused on optimizing persistence in performance of specific selected activities. | Behavioural | Intervention |
Primary outcome
Occupational Resilience Measure (ORM 1.0)
Time frame: Week 7-8; Week 22-23
The ability to persist in selected daily activity despite challenges
2 secondary outcomes
World Health Organization Quality of Life Scale (WHOQOL-BREF)
Time frame: Week 7-8; Week 22-23
Psychological Wellbeing Scale
Time frame: Week 7-8; Week 22-23
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 10 Sep 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ActiveHeal in people with Prostate Cancer and Breast Cancer, run by University of Arkansas 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 5 inclusion and 0 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 10 Sep 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?
Occupational Resilience Measure (ORM 1.0) (time frame: Week 7-8; Week 22-23). 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 10 Sep 2025.