Advanced CancerCASANCT06883058
Caregivers-Patients Support Coping With Advanced-Cancer (CASA) Intervention
A study testing Caregivers-patients support intervention for advanced cancer (CASA) in people with Advanced Cancer and Caregivers, run by Ponce Medical School Foundation, Inc. at 1 site in Puerto Rico.
Trial summary
This pilot aims to prepare the PI to receive hands-on experience in implementation and dissemination and design and lead pilot studies in palliative care. The catchment area communities experience lower cancer health outcomes and are more likely to be diagnosed with advanced cancer when compared to other surrounding… Read more about this study
- Who is it for?
- Ages 21 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Advanced Cancer, Caregivers, Patients
- What is being tested?
- Caregivers-patients support intervention for advanced cancer (CASA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 1 Jan 2026to 30 Jul 2027
- 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 21 to 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cancer patients must be stage III and IV solid tumor patients who report distress >4 on the Distress Thermometer
- Caregivers. Identified caregivers by distressed patients.
Who cannot join
- diagnosed with a major disabling medical or psychiatric condition
- unable to understand the consent procedure, or (3) too ill to participate, all as reported by the participant and/or determined by the investigator's judgment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This pilot aims to prepare the PI to receive hands-on experience in implementation and dissemination and design and lead pilot studies in palliative care. The catchment area communities experience lower cancer health outcomes and are more likely to be diagnosed with advanced cancer when compared to other surrounding areas. The PI's catchment area experiences advanced cancer, and their caregivers are at an increased risk for unmet psychosocial needs; this pre-pilot will allow the PI to focus on this critical gap in equal healthcare. The research goal of this proposal is to refine and pre-pilot an intervention titled Caregivers Patients Support to Cope with Advanced Cancer (CASA), a five-session, 60-minute telehealth series for patient-caregiver dyads. The rationale for this project is that it will lay the groundwork for a Randomized Control Trial (RCT) testing the efficacy of CASA. It will also assess the implementation of an innovative method to deliver the CASA intervention. This study aims to use the collaborative intervention planning framework and ORBIT model to modify and assess the feasibility and preliminary effect of the CASA intervention. The overall impact of this study is to improve access to psychosocial interventions in the proposed catchment area.
Read the detailed description
The proposed study will follow a mixed-methods pilot study. The intervention trial will involve conducting an adapted Caregivers-Patients Support intervention to Cope with Advanced-Cancer (CASA) randomized clinical trial framed under the the collaborative intervention planning framework. The team will collect data for primary outcome (Spiritual Well-Being Scale) and secondary outcomes. The secondary outcomes include Hospital Anxiety and Depression Scale (HADS), Beck Hopelessness Scale (BHS), Functional Assessment of Cancer Therapy-General (FACT-G), Family Relationship Index, Holding Back subscale, Zarit Burden Interview (ZBI), and NCCN Distress Thermometer. All measures are available in Spanish and the team has used them in previous studies with Hispanic/Latinx patients and caregivers coping with advanced cancer. Highly innovative analyses exploring feasibility and preliminary effect. Definitions of feasibility will include: (1) ≥60% enrollment among approached participants, (2) ≥70% completion of baseline and T2 surveys; (3) ≥80% of participants in the intervention group agreeing with the item CASA was helpful to me; and (4) ≤20% of respondents in the intervention group agreeing with the item CASA placed a considerable burden on me. Preliminary effects evaluation will include: a linear mixed effect modeling and an intent-to-treat approach to analyze the results. The results of FACIT, FRI, HBS, HADS, BHS, DT, FACT-G, and ZB will be analyzed with a paired t-test, Wilcoxon signed ranks test, and McNemar. Linear mixed effect modeling is statistically appropriate because we will use one independent variable (CASA intervention) with more than two dependent/matched groups (patients-control, caregivers-control, patients-in-treatment, caregivers-in-treatment, patients-caregiver-control, and patients-caregivers-in-treatment). The primary outcome is pre- to post-intervention changes in spirituality (FACIT). Change scores have the advantage of clearly showing the direction of change. The linear mixed effects model analysis will include two primary fixed-effect covariates: 1) spirituality to provide some control over variability in participants baseline; and 2) treatment assignment (CASA vs. control group). The same approach will be used for the secondary outcomes (FACT-IT, HADS, BHS, DT, FACT-G, and ZB). Qualitative Analyses. Interviews will be digitally recorded with consent and analyzed thematically using a matrix. Each thematic matrix will contain data from the interviews pertaining to the theme in question, alongside participant information (demographics, changes in scores). The qualitative analysis will help explain the feasibility/acceptability. The team will implement minor refinements to enhance the relevance of the CASA intervention for the target population and context.
- Conditions
- Advanced Cancer, Caregivers, Patients, Stage III Cancer, Stage IV Cancer
- Being tested
- Caregivers-patients support intervention for advanced cancer (CASA), Placebo
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregivers-patients support intervention for advanced cancer (CASA)Behavioural
The Caregivers-Patients Support Intervention for Advanced Cancer (CASA) will be delivered to patients and caregivers. The sessions follow a protocol and will be held weekly or bi-weekly for a total of 5 sessions.
PlaceboBehavioural
Usual care will be provided to participants in the control group. The usual care consists of symptom management once a week and 5 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Placebo comparator | Usual care will be provided to participants in the control group. The usual care consists of symptom management once a week and 5 sessions. Receives: Behavioral: Placebo |
| CASA | Experimental | The Caregivers-Patients Support Intervention for Advanced Cancer (CASA) will be delivered to patients and caregivers. The sessions follow a protocol and will be held weekly or bi-weekly for a total of 5 sessions. Receives: Behavioral: Caregivers-patients support intervention for advanced cancer (CASA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Chronic Illness Therapy-spiritual well-being (FACIT-Sp)
The Functional Assessment of Chronic Illness Therapy-spiritual well-being (FACIT-Sp) is a 12-item measure of spiritual well-being designed for individuals with cancer and other chronic illnesses. Item development was informed by input from cancer patients, psychotherapists, and religious/spiritual experts. The measure will be administered at baseline (one to two weeks prior to the intervention) and post-intervention (one to two weeks following completion of the intervention). Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp-12) range from 0 to 48, with higher scores indicating greater spiritual well-being.
Measured: 5 minutes; the measure will be administered pre and post intervention (one to two weeks before the intervention and one to two weeks after the intervention)
Secondary outcomes (2)
Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. the measure will be administered pre and post intervention (one to two weeks before the intervention and one to two weeks after the intervention). The Patient Health Questionnaire-9 total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.
Measured: 5 minutes; the measure will be administered pre and post intervention (one to two weeks before the intervention and one to two weeks after the intervention)
Generalized Anxiety Disorder-7 (GAD-7)
The Generalized Anxiety Disorder 7-item (GAD-7) is an easy to perform initial screening tool for generalized anxiety disorder. The measure will be administered pre and post intervention (one to two weeks before the intervention and one to two weeks after the intervention). The Generalized Anxiety Disorder 7-item scale total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.
Measured: 5 minutes; the measure will be administered pre and post intervention (one to two weeks before the intervention and one to two weeks after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start1 Jan 2026
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ponce Medical School Foundation, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Normarie Torres-Blasco, Ponce Medical School Foundation, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883058
- Sponsor's protocol ID
- 2411224820
- Acronym
- CASA
- Status last verified
- Jun 2026
- First submitted
- 12 Mar 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregivers-Patients Support Coping With Advanced-Cancer (CASA) Intervention
- ClinicalTrials.gov ID
- NCT06883058
- Acronym / sponsor ID
- CASA / 2411224820
- Conditions
- Advanced Cancer, Caregivers, Patients, Stage III Cancer, Stage IV Cancer
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Ponce Medical School Foundation, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 19 Mar 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.
This pilot aims to prepare the PI to receive hands-on experience in implementation and dissemination and design and lead pilot studies in palliative care. The catchment area communities experience lower cancer health outcomes and are more likely to be diagnosed with advanced cancer when compared to other surrounding areas. The PI's catchment area experiences advanced cancer, and their caregivers are at an increased risk for unmet psychosocial needs; this pre-pilot will allow the PI to focus on this critical gap in equal healthcare. The research goal of this proposal is to refine and pre-pilot an intervention titled Caregivers Patients Support to Cope with Advanced Cancer (CASA), a five-session, 60-minute telehealth series for patient-caregiver dyads. The rationale for this project is that it will lay the groundwork for a Randomized Control Trial (RCT) testing the efficacy of CASA. It will also assess the implementation of an innovative method to deliver the CASA intervention. This study aims to use the collaborative intervention planning framework and ORBIT model to modify and assess the feasibility and preliminary effect of the CASA intervention. The overall impact of this study is to improve access to psychosocial interventions in the proposed catchment area.
Detailed description
The proposed study will follow a mixed-methods pilot study. The intervention trial will involve conducting an adapted Caregivers-Patients Support intervention to Cope with Advanced-Cancer (CASA) randomized clinical trial framed under the the collaborative intervention planning framework. The team will collect data for primary outcome (Spiritual Well-Being Scale) and secondary outcomes. The secondary outcomes include Hospital Anxiety and Depression Scale (HADS), Beck Hopelessness Scale (BHS), Functional Assessment of Cancer Therapy-General (FACT-G), Family Relationship Index, Holding Back subscale, Zarit Burden Interview (ZBI), and NCCN Distress Thermometer. All measures are available in Spanish and the team has used them in previous studies with Hispanic/Latinx patients and caregivers coping with advanced cancer. Highly innovative analyses exploring feasibility and preliminary effect. Definitions of feasibility will include: (1) ≥60% enrollment among approached participants, (2) ≥70% completion of baseline and T2 surveys; (3) ≥80% of participants in the intervention group agreeing with the item CASA was helpful to me; and (4) ≤20% of respondents in the intervention group agreeing with the item CASA placed a considerable burden on me. Preliminary effects evaluation will include: a linear mixed effect modeling and an intent-to-treat approach to analyze the results. The results of FACIT, FRI, HBS, HADS, BHS, DT, FACT-G, and ZB will be analyzed with a paired t-test, Wilcoxon signed ranks test, and McNemar. Linear mixed effect modeling is statistically appropriate because we will use one independent variable (CASA intervention) with more than two dependent/matched groups (patients-control, caregivers-control, patients-in-treatment, caregivers-in-treatment, patients-caregiver-control, and patients-caregivers-in-treatment). The primary outcome is pre- to post-intervention changes in spirituality (FACIT). Change scores have the advantage of clearly showing the direction of change. The linear mixed effects model analysis will include two primary fixed-effect covariates: 1) spirituality to provide some control over variability in participants baseline; and 2) treatment assignment (CASA vs. control group). The same approach will be used for the secondary outcomes (FACT-IT, HADS, BHS, DT, FACT-G, and ZB). Qualitative Analyses. Interviews will be digitally recorded with consent and analyzed thematically using a matrix. Each thematic matrix will contain data from the interviews pertaining to the theme in question, alongside participant information (demographics, changes in scores). The qualitative analysis will help explain the feasibility/acceptability. The team will implement minor refinements to enhance the relevance of the CASA intervention for the target population and context.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Placebo comparator | Behavioral: PlaceboUsual care will be provided to participants in the control group. The usual care consists of symptom management once a week and 5 sessions. |
| CASA | Experimental | Behavioral: Caregivers-patients support intervention for advanced cancer (CASA)The Caregivers-Patients Support Intervention for Advanced Cancer (CASA) will be delivered to patients and caregivers. The sessions follow a protocol and will be held weekly or bi-weekly for a total of 5 sessions. |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cancer patients must be stage III and IV solid tumor patients who report distress >4 on the Distress Thermometer
- Caregivers. Identified caregivers by distressed patients.
Key exclusion criteria (2 listed)
- diagnosed with a major disabling medical or psychiatric condition
- unable to understand the consent procedure, or (3) too ill to participate, all as reported by the participant and/or determined by the investigator's judgment.
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 |
|---|---|---|
| Caregivers-patients support intervention for advanced cancer (CASA)The Caregivers-Patients Support Intervention for Advanced Cancer (CASA) will be delivered to patients and caregivers. The sessions follow a protocol and will be held weekly or bi-weekly for a total of 5 sessions. | Behavioural | CASA |
| PlaceboUsual care will be provided to participants in the control group. The usual care consists of symptom management once a week and 5 sessions. | Behavioural | Usual Care |
Primary outcome
Functional Assessment of Chronic Illness Therapy-spiritual well-being (FACIT-Sp)
Time frame: 5 minutes; the measure will be administered pre and post intervention (one to two weeks before the intervention and one to two weeks after the intervention)
The Functional Assessment of Chronic Illness Therapy-spiritual well-being (FACIT-Sp) is a 12-item measure of spiritual well-being designed for individuals with cancer and other chronic illnesses. Item development was informed by input from cancer patients, psychotherapists, and religious/spiritual experts. The measure will be administered at baseline (one to two weeks prior to the intervention) and post-intervention (one to two weeks following completion of the intervention). Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp-12) range from 0 to 48, with higher scores indicating greater spiritual well-being.
2 secondary outcomes
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 5 minutes; the measure will be administered pre and post intervention (one to two weeks before the intervention and one to two weeks after the intervention)
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 5 minutes; the measure will be administered pre and post intervention (one to two weeks before the intervention and one to two weeks after the intervention)
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 9 Jun 2026.
- Individual participant dataSharing planned: Yes
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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.
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 Caregivers-patients support intervention for advanced cancer (CASA) in people with Advanced Cancer and Caregivers, run by Ponce Medical School Foundation, Inc. at 1 site in Puerto Rico.
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 2 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: enrolling by invitation, as of the sponsor's last update on 9 Jun 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 Puerto Rico. 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. Some participants in this study may receive a placebo. 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?
Functional Assessment of Chronic Illness Therapy-spiritual well-being (FACIT-Sp) (time frame: 5 minutes; the measure will be administered pre and post intervention (one to two weeks before the intervention and one to two weeks after the intervention)). 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 9 Jun 2026.