Trial Title:
A Trial for a Preliminary Estimate of the Effectiveness of a Novel Theoretical Framework
NCT ID:
NCT06461416
Condition:
Prostate Cancer
Breast Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
The study will utilize the randomized study design with two groups of 20 participants in
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.
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
ActiveHeal
Description:
Participants will have 6 group activity sessions and six individualized sessions from
home, all focused on optimizing persistence in performance of specific selected
activities.
Arm group label:
Intervention
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)].
- 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 20 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, 11,13, 15,
17 &19 (Week 1, 3, 5, 7, 9 & 11 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, highlighting History, Experience, Benefits, and Adaptation (Location: UAMS
Northwest Campus). 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. Four additional therapists will be trained by PI in a 60 minute
group session, to be able lead individual or group sessions.
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) undertake an activity as a group, 2) reflect or share how
they have or could apply this activity to support health, and 3) develop a feasible plan
for its application 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) an activity for each session used to facilitate learning.
Tentatively, the session themes include:
Everyday enjoyment of music Adaptation - What if I can't do it today? Developing and
sustaining habits Therapeutic use of arts and crafts Applying meditation practices Making
healthy eating a habit
Session themes about content will be retained regardless of the kind of activities
selected by group members, but activities 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 activity selected, 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, 12, 14, 16, 18 & 20 (Week 2, 4, 6, 8, 10 & 12 of the ActiveHeal EST
(Engage-Sustain-Triumph) Program) Six Individualized ActiveHeal EST
(Engage-Sustain-Triumph) Sessions (Group A only): Each participant in the experiment
group will receive 6 occupational therapy visits at their home or other selected
location. This session will focus on the activities that the participants selected at the
start of the program. Using the methods covered in group sessions to strengthen activity
performance, with individualized occupational therapy intervention added. All
interventions will focus on building History, Experience, Benefits, and Adaptation. 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.
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 21-22 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).
Criteria for eligibility:
Criteria:
Inclusion Criteria
- Must be an adult, diagnosed with prostate or breast cancer within 6 months before
the date recruitment starts.
- Must be 18-75 years old.
- Must score 80 to 90 on the Karnofsky Performance Status Scale (KPSS) Exclusion
Criteria
- Unable to attend sessions at the University of Arkansas for Medical Sciences
(northwest campus) Fayetteville
- Unable or unwilling to participate in activities.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Arkansas for Medical Science
Address:
City:
Fayetteville
Zip:
72203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bernard K Muriithi, PhD
Phone:
480-665-1643
Email:
bmuriithi@uams.edu
Investigator:
Last name:
Bernard K Muriithi, PhD
Email:
Principal Investigator
Investigator:
Last name:
Mario Schootman, PhD
Email:
Sub-Investigator
Start date:
June 10, 2024
Completion date:
December 30, 2024
Lead sponsor:
Agency:
University of Arkansas
Agency class:
Other
Source:
University of Arkansas
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06461416
