NeoplasmsHACERNCT06018311
Hispanic Adapted and Culturally Relevant Exercising Together
A study testing Exercising together in people with Neoplasms and Prostate Cancer, run by University of Arizona at 1 site in United States.
Trial summary
The purpose of this study is to determine the feasibility and effects of an adapted Exercising Together, a partnered resistance training program, on the physical and mental health of prostate cancer survivors and their informal caregiver. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Neoplasms, Prostate Cancer, Exercise
- What is being tested?
- Exercising together
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identifies as Hispanic
- Histologically confirmed prostate cancer diagnosis (self-report)
- Completed primary treatment at least 6 weeks prior at time of enrollment
- Has an identified caregiver in any relationship role (e.g., spouse, sibling, parent, friend) who can participate with them.
- 1. Identifies as an individual (e.g., family member or friend) who provides unpaid care or support to a participating prostate cancer survivor.
- ≥18 years of age
Show all 16Show fewer
- Understands (ability to read and speak) English or Spanish and able to provide informed consent
- Meets the American College of Sports Medicine pre-participation screening criteria for exercise
- Ability to ambulate (with or without assistive devices)
- Willing to attend study group exercise classes online, complete remote assessments, and answer online surveys
- Has access to a mobile device with camera and internet.
- Able to participate in classes at same time as other participating member.
- Histologically confirmed cancer diagnosis (self-report)
- Completed primary treatment at least 6 weeks prior at time of enrollment
- Has an identified caregiver in any relationship role (e.g., spouse, sibling, parent, friend) who can participate with them.
- Inclusion Criteria for Caregivers remains the same as Phase 1 Exclusion Criteria remain the same as Phase 1
Who cannot join
- Cognitive difficulties that preclude answering the survey questions, participating in the exercise classes or performance tests, or providing informed consent as determined by the professional opinion of the Principal Investigator
- A medical condition, movement or neurological disorder, or medication use that contraindicates participation in moderate intensity exercise or poses a significant safety concern/risk for the well-being of the participant (e.g., declared pregnancy, poorly controlled diabetes, recent cardiac event, neuromuscular disease, untreated orthostatic hypertension, recent surgery, acute hernia, acute rheumatoid arthritis, severe memory disorders, severe balance disorder, severe hearing or vision impairment)
- Knowingly unable to attend >75% of the intervention classes due to conflict with the designated time of day, days of the week, and/or location for the exercise class which they initially enrolled
- Incapable of providing informed consent, answering survey questions, participating in the intervention, and following directions during performance testing when English or Spanish language is used
- Unable to be in the same location with participating member during remote exercise classes and performance testing and/or insufficient internet connectivity to support required videoconferencing software
- Phase 2:
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona Cancer Center
Tucson, Arizona, 85719
About this study
Official title: A Pilot Feasibility Study of a Culturally Adapted Partnered Strength Training Intervention for Hispanic Cancer Survivors and Their Caregivers
The purpose of this study is to determine the feasibility and effects of an adapted Exercising Together, a partnered resistance training program, on the physical and mental health of prostate cancer survivors and their informal caregiver. The Exercising Together program is designed to promote teamwork during supervised group exercise classes delivered remotely through videoconferencing software. The intervention period will be 3-months with a 3-month follow-up.
- Conditions
- Neoplasms, Prostate Cancer, Exercise, Caregiver Burden, Cancer Survivors
- Being tested
- Exercising together
- Keywords
- caregivers, Cancer survivorship, Hispanic Men's Health, Strength training, Pilot study
- Medical subject headings
- Neoplasms, Prostatic Neoplasms, Motor Activity, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercising togetherBehavioural
The Exercising Together program is a partnered functional strength training program that encourages participating dyads to interact with one another, verbally and physically, during exercise sessions. In Exercising Together, the survivor and their caregiver will build skills to work as a team. We will incorporate skills that promote and reinforce communication, motivation, and support and use this to guide training of survivor-caregiver dyads to maximize their teamwork during each exercise session. Group sessions are delivered remotely through videoconferencing software and are supervised by two trained exercise instructors. Intervention and assessment is available in English or Spanish.
| Study group | Role | What they receive |
|---|---|---|
| Exercising Together | Experimental | Dyads perform partnered exercise over 1 hour, 3 days per week in a supervised, group setting remotely for 3 months. Receives: Behavioral: Exercising together |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability measured by adherence to intervention
Acceptability will be measured by adherence to the intervention calculated as the total number of classes attended divided by the total possible schedule the patient could attend using descriptive statistics.
Measured: 3 months
Appropriateness measured by retention rate
Will be determined as the retention rate- calculated as the number of dyads completing the study versus consented using descriptive statistics.
Measured: 3 months
Feasibility measured by enrollment rate
Will be determined as the enrollment rate- the number of dyads enrolled out of those approached and eligible using descriptive statistics.
Measured: 3 months
Implementation Success - composite measure of acceptability, appropriateness, and feasibility.
Implementation success is a composite measure that will be measured by a single questionnaire that will determine the extent to which the intervention is considered acceptable, appropriate, and feasible. The single questionnaire will consist of 3 measures that will be summed into one final score, The Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Responses from AIM, IAM, and FIM are summary scored with a possible range of 12-60; higher scores indicate greater acceptability, appropriateness, and feasibility.
Measured: 3 months
Secondary outcomes (5)
Physical activity
Moderate to vigourous physical activity and sedentary time estimated using Rapid Assessment of Physical Activity (RAPA)
Measured: Physical activity will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.
Health-Related Quality of Life (HR-QOL) for the caregiver
Measured by the 27 item Functional Assessment of Cancer Therapy - General (FACT-G), which includes subscales on physical, social, emotional, and functional well-being. Response items are five-point Likert scales, where higher scores indicate higher HR-QOL.
Measured: HR-QOL will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.
Health-Related Quality of Life (HR-QOL) for the survivor
Measured by the 39 item Functional Assessment of Cancer Therapy - Prostate (FACT-P), which includes subscales on physical, social, emotional, and functional well-being and an additional subscale specific to prostate cancer. Response items are five-point Likert scales, where higher scores indicate higher HR-QOL.physical, social, emotional, and functional well-being. FACT-G is 27 items while FACT-P is 39 items. FACT-P includes an additional subscale specific to prostate cancer. Response items are five-point likert scales, where higher scores indicate higher HR-QOL.
Measured: HR-QOL will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.
Relationship Health
Measured by the Relationship Quality Index (RQI), a six-item assessment of communication and satisfaction on a five-point likert scale.
Measured: Relationship Health will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.
Objective Physical Function
Measured by the Short Physical Performance Battery (SPPB) to determine ability to perform tasks of daily living independently. The SPPB includes 3 timed tests: 5 repeated chair stands, standing balance, and gait speed over 4 meters. The possible range of scores is 0-12.
Measured: Objective Physical Function will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start1 Nov 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meghan B Skiba, PhD, MS, MPH, RDN, Principal investigator, University of Arizona College of Nursing Biobehavioral Health Science Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018311
- Sponsor's protocol ID
- STUDY00003138
- Acronym
- HACER
- Status last verified
- Mar 2026
- First submitted
- 11 Aug 2023
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Study of a Culturally Adapted Partnered Strength Training Intervention for Hispanic Cancer Survivors and Their Caregivers
- ClinicalTrials.gov ID
- NCT06018311
- Acronym / sponsor ID
- HACER / STUDY00003138
- Conditions
- Neoplasms, Prostate Cancer, Exercise, Caregiver Burden, Cancer Survivors
- Keywords
- caregivers, Cancer survivorship, Hispanic Men's Health, Strength training, Pilot study
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Aug 2023 (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 purpose of this study is to determine the feasibility and effects of an adapted Exercising Together, a partnered resistance training program, on the physical and mental health of prostate cancer survivors and their informal caregiver. The Exercising Together program is designed to promote teamwork during supervised group exercise classes delivered remotely through videoconferencing software. The intervention period will be 3-months with a 3-month follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercising Together | Experimental | Behavioral: Exercising togetherDyads perform partnered exercise over 1 hour, 3 days per week in a supervised, group setting remotely for 3 months. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Self-identifies as Hispanic
- Histologically confirmed prostate cancer diagnosis (self-report)
- Completed primary treatment at least 6 weeks prior at time of enrollment
- Has an identified caregiver in any relationship role (e.g., spouse, sibling, parent, friend) who can participate with them.
- 1. Identifies as an individual (e.g., family member or friend) who provides unpaid care or support to a participating prostate cancer survivor.
Key exclusion criteria (6 listed)
- Cognitive difficulties that preclude answering the survey questions, participating in the exercise classes or performance tests, or providing informed consent as determined by the professional opinion of the Principal Investigator
- A medical condition, movement or neurological disorder, or medication use that contraindicates participation in moderate intensity exercise or poses a significant safety concern/risk for the well-being of the participant (e.g., declared pregnancy, poorly controlled diabetes, recent cardiac event, neuromuscular disease, untreated orthostatic hypertension, recent surgery, acute hernia, acute rheumatoid arthritis, severe memory disorders, severe balance disorder, severe hearing or vision impairment)
- Knowingly unable to attend >75% of the intervention classes due to conflict with the designated time of day, days of the week, and/or location for the exercise class which they initially enrolled
- Incapable of providing informed consent, answering survey questions, participating in the intervention, and following directions during performance testing when English or Spanish language is used
- Unable to be in the same location with participating member during remote exercise classes and performance testing and/or insufficient internet connectivity to support required videoconferencing software
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 |
|---|---|---|
| Exercising togetherThe Exercising Together program is a partnered functional strength training program that encourages participating dyads to interact with one another, verbally and physically, during exercise sessions. In Exercising Together, the survivor and their caregiver will build skills to work as a team. We will incorporate skills that promote and reinforce communication, motivation, and support and use this to guide training of survivor-caregiver dyads to maximize their teamwork during each exercise session. Group sessions are delivered remotely through videoconferencing software and are supervised by two trained exercise instructors. Intervention and assessment is available in English or Spanish. | Behavioural | Exercising Together |
Primary outcome
Acceptability measured by adherence to intervention
Time frame: 3 months
Acceptability will be measured by adherence to the intervention calculated as the total number of classes attended divided by the total possible schedule the patient could attend using descriptive statistics.
Appropriateness measured by retention rate
Time frame: 3 months
Will be determined as the retention rate- calculated as the number of dyads completing the study versus consented using descriptive statistics.
Feasibility measured by enrollment rate
Time frame: 3 months
Will be determined as the enrollment rate- the number of dyads enrolled out of those approached and eligible using descriptive statistics.
Implementation Success - composite measure of acceptability, appropriateness, and feasibility.
Time frame: 3 months
Implementation success is a composite measure that will be measured by a single questionnaire that will determine the extent to which the intervention is considered acceptable, appropriate, and feasible. The single questionnaire will consist of 3 measures that will be summed into one final score, The Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Responses from AIM, IAM, and FIM are summary scored with a possible range of 12-60; higher scores indicate greater acceptability, appropriateness, and feasibility.
5 secondary outcomes
Physical activity
Time frame: Physical activity will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.
Health-Related Quality of Life (HR-QOL) for the caregiver
Time frame: HR-QOL will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.
Health-Related Quality of Life (HR-QOL) for the survivor
Time frame: HR-QOL will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.
Relationship Health
Time frame: Relationship Health will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.
Objective Physical Function
Time frame: Objective Physical Function will be measured over a 6 month period. It will be measured at baseline, 3 months, and 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Neoplasms
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingPhase 1/2
A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)
Colorectal Cancer, Pancreatic Ductal Adenocarcinoma
RecruitingPhase 3
A Study of Raludotatug Deruxtecan With or Without Bevacizumab as First-Line Maintenance Treatment in Non-HRD-Positive Advanced Ovarian Cancer (MK-5909-006, (ENGOT-ov102/GOG-3141/ REJOICE-Ovarian 04)
Ovarian Cancer, Ovarian Neoplasms
RecruitingPhase 1/2
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
Lymphoma, Non-Hodgkin Lymphoma
RecruitingPhase 3
Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
Acute Promyelocytic Leukemia (APL), Acute Promyelocytic Leukaemia
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.
Meghan B Skiba, PhD, MS, MPH, RDN principal investigator
University of Arizona College of Nursing Biobehavioral Health Science Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercising together in people with Neoplasms and Prostate Cancer, run by University of Arizona 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 16 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 measured by adherence to intervention (time frame: 3 months). The study lists 4 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 20 Mar 2026; AzTrials last refreshed its copy on 29 Oct 2026.