Advanced Malignant Solid NeoplasmNCT04697524
Integrative Palliative Care/Psycho-Oncology Telehealth Intervention in Patients With Advanced Cancer
A study testing Support Group Therapy, Symptom Management Service (SMS) Consultation and Quality of Life (QOL) Questionnaires in people with Advanced Malignant Solid Neoplasm and Locally Advanced Malignant Solid Neoplasm, run by University of California, San Francisco at 1 site in United States.
Trial summary
This trial investigates whether a joint and integrative approach to cancer care using palliative care and psycho-oncology is possible, and if it's beneficial to patients with cancer that has spread to other places on the body (advanced). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Solid Neoplasm, Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm
- What is being tested?
- Support Group Therapy, Symptom Management Service (SMS) Consultation and Quality of Life (QOL) Questionnaires
- 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
- 26 Jan 2021to 31 May 2023
- 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
- Carry a diagnosis of an advanced solid tumor cancer (locally advanced or metastatic, i.e., stage III or IV cancer)
- Be age >= 18 years
- Be able to speak and read English
- Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet (assessed by participant self-report)
- Be capable of independently utilizing an online platform for telehealth group medical visits in a private setting (assessed by participant self-report)
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
- Be able to understand a written informed consent document, and be willing to sign it
Who cannot join
- Have a cognitive or psychiatric condition prohibiting study consent or participation determined by co-principal investigators (PIs) or referring provider
- Be too medically unstable (or expected to become so during the study period) to participate in a telehealth group medical visit determined by co-PIs or referring providers
- Does not have insurance coverage for telehealth group medical visits
- Have extensive hearing loss such that ability to participate in the study would be impaired as determined by co-PIs or referring provider
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Integrative Palliative Care/Psycho-Oncology Telehealth Group Medical Visits for Patients With Advanced Cancer: A Pilot Study
This trial investigates whether a joint and integrative approach to cancer care using palliative care and psycho-oncology is possible, and if it's beneficial to patients with cancer that has spread to other places on the body (advanced). The information gained from this study may help patients to learn about the medicinal and non-medicinal strategies to cope with their symptoms and side effects of their diagnosis and treatment while receiving peer support, in addition to standard individualized medical care.
Read the detailed description
PRIMARY OBJECTIVES:
- To develop and refine a joint Integrative Palliative Care/Psycho-oncology telehealth group medical visit (GMV) intervention based on feedback from an open pilot study with patient exit interviews.
II. To determine the feasibility and acceptability of the telehealth GMVs in a separate, single-arm pilot evaluation among patients with advanced cancer.
SECONDARY OBJECTIVE:
- To estimate the preliminary efficacy of the GMVs among patients with advanced cancer.
EXPLORATORY OBJECTIVES:
- To assess the financial viability of the GMVs. II. To measure the utilization of other supportive care services at Helen Diller Family Comprehensive Cancer Center (HDFCCC) and the Osher Center 3 months post-treatment.
III. To measure the University of California San Francisco (UCSF) healthcare utilization of participants 3 months post treatment.
OUTLINE:
PHASE I: The group-based intervention is developed, tested, and continuously refined based on participant feedback. Within 14 days of the first weekly group intervention, patients complete baseline questionnaires over 30-45 minutes about their sleep habits, pain management, anxiety/depression, and other symptoms. Patients then participate in a telehealth group medical intervention program over 2 hours weekly for up to 4 sessions where they review topics specific to managing fatigue and sleep habits, managing pain, managing emotional distress, and managing other symptoms and advanced care planning. During the weekly sessions, patients have the opportunity to meet with their symptom management service (SMS) provider in a separate virtual space for individual consultation over 5 minutes to discuss symptoms that they do not feel comfortable sharing in the larger group. The SMS provider may recommend specific interventions or resources for patients to discuss with their oncology, primary care, integrative medicine, psycho-oncology, or palliative care providers as appropriate. Patients also participate in an exit interview over 30 minutes to 1 hour.
PHASE II: Based on the feedback given in the first phase, three new cohorts of participants are recruited to assess the acceptability and feasibility of the refined intervention using similar procedures as in Phase I.
After completion of study, patients are followed up at 7 and 14 days, and then up to 3 months.
- Conditions
- Advanced Malignant Solid Neoplasm, Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm
- Being tested
- Support Group Therapy, Symptom Management Service (SMS) Consultation, Quality of Life (QOL) Questionnaires, Interview
- Keywords
- Telehealth, Palliative Care
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Support Group TherapyBehavioural
Also called Virtual Visit, Telehealth
Virtual group meetings
Symptom Management Service (SMS) ConsultationBehavioural
Also called SMS, Virtual Visit
Virtual individual meetings with symptom management service (SMS) over 5 minutes
Quality of Life (QOL) QuestionnairesOther
Administered at each study visit
InterviewOther
Also called Virtual Visit
Virtual exit interview at end of study
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Supportive care (GMV) | Experimental | Participants will take a baseline assessment to collect socio-demographic information and complete a series of patient-reported outcome assessments (PROs) prior to their first group medical visit (GMV). The GMV intervention will take place over four weekly sessions conducted virtually. At the completion of all four weekly GMV sessions, participants will be asked to complete an exit survey. Participants in phase one will not be contacted or followed after the exit survey. Receives: Behavioral: Support Group Therapy; Behavioral: Symptom Management Service (SMS) Consultation; Other: Quality of Life (QOL) Questionnaires; Other: Interview |
| Phase 2: Refined GMV | Experimental | Up to three new cohorts of participants are recruited to assess the acceptability and feasibility of the refined intervention based on the results from the Phase 1 group Receives: Behavioral: Support Group Therapy; Behavioral: Symptom Management Service (SMS) Consultation; Other: Quality of Life (QOL) Questionnaires; Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop Categories for intervention refinement (Phase 1)
Qualitative methods to analyze participant feedback obtained during exit interviews and code notes from by the existing domains: session relevance, delivery mode, ease of participation, suggested changes. A thematic content analysis will be performed to determine themes based on patterns and responses in these categories. Two coders will then meet to discuss the themes and reach agreement on final categories used to refine intervention for Phase 2 participants.
Measured: Up to 3 months
Proportion of participants enrolled
The proportion of eligible and approached patients who consent to participate.
Measured: 14 days
Retention rate
The percentage of patients who complete pre and post-treatment questionnaires.
Measured: Up to 3 months
Adherence rate
Percentage of patients who complete 2 or more sessions. Will use one-sample negative binomial probability and tests of binomial proportions to compare rates of feasibility to hypothesized values.
Measured: Up to 3 months
Number of participants deemed ineligible or refusing to participate
Number of participants who are determined to be ineligible before 1st virtual visit or refusal to participate before 1st visit and during treatment.
Measured: Up to 3 months
Frequency of Participant Ineligibility Reason
For potential study candidates who are ineligible, we will log reasons for ineligibility
Measured: Up to 14 days
Frequency of Participant Refusal Reason
For potential study candidates who decide not to participate, we will log reasons for refusal.
Measured: Up to 14 days
Mean post-treatment participant satisfaction ratings
Participant ratings on intervention convenience, helpfulness, recommendation to others, worth doing, and feeling connected with University of California, San Francisco (UCSF). Descriptive statistics (frequencies, means, and standard deviations (SDs)) and 95% confidence intervals will summarize patients' ratings
Measured: 1 day
Secondary outcomes (10)
Change in distress score on the Edmonton Symptom Assessment System (ESAS)
This 8-item questionnaire is used currently in the Symptom Management Service (SMS) and completed at each visit which measures severity at the time of assessment of each symptom and is rated from 0 to 10 on a numerical scale; with 0 meaning that the symptom is absent and 10 that it is the worst possible severity items (pain, activity, nausea, depression, anxiety, drowsiness, appetite, and sensation of well-being) . The sum of the scores for all symptoms is defined as the symptom distress score.
Measured: Up to 3 months
Change in scores on the Patient Health Questionnaire-8 (PHQ-8)
The PHQ-8 is used to measure depression symptoms. The total Patient Health Questionnaire-8 (PHQ-8) score is calculated by combining the responses of the participant on questions addressing how bothered the participant has been by various problems over the past 2 weeks. Each of the 8 items is scored on a scale of 0 ("Not bothered at all") to 4 ("Nearly every day"). A total score of 0-4= No depression, 5-9='Mild Depression", 10-4="Moderate Depression", 15-19="Moderately severe depression", and 20 or higher ="Severe Depression".
Measured: Up to 3 months
Change in score on the Generalized Anxiety Disorder Assessment (GAD-7)
The GAD-7 is a seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, and then adding together the scores for the seven questions. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater
Measured: Up to 3 months
Change in score on the Patient Reported Outcomes Measurement Information System-Cancer (PROMIS) Pain Interference- Short Form 4a
This 4-item questionnaire to measure the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities based on responses to statements about how the participants feel with a with a response ranging from 1="Never" to 5="Always", and a total raw score ranging from 4 - 20, which are converted to a scaled T-score (range 41.6 to 75.6) with higher scores indicating a greater hinderance to engagement in activities based on how much pain participants are experiencing.
Measured: Up to 3 months
Change in score on the PROMIS Sleep Disturbance- Short Form 6a
This 6-item questionnaire to measure sleep disturbance based on responses to statements about how the participants feel with a response ranging from 1="Never" to 5="Always", and a total raw score ranging from 6 - 30, which are converted to a scaled T-score (range 31.7 to 73.3) with higher scores indicating a greater feeling of sleep disturbance.
Measured: Up to 3 months
Change in score on the PROMIS Fatigue - Short Form 6a
This 6-item questionnaire to measure fatigue based on responses to statements about how the participants feel with a response ranging from 1="Never" to 5="Always", and a total raw score ranging from 6 - 30, which are converted to a scaled T-score (range 33.4 to 76.8) with higher scores indicating a greater feeling of fatigue.
Measured: Up to 3 months
Change in score on the PROMIS Social Isolation -Short Form 4a Short Form 4a
This 4-item questionnaire to measure social isolation based on responses to statements about how the participants feel with a response ranging from 1="Never" to 5="Always", and a total score ranging from 4 - 20 which are converted to a scaled T-score (range 34.8 to 74.2) with higher scores indicating a greater feeling of social isolation.
Measured: Up to 3 months
Change in score on the Cancer Behavior Inventory-Brief (CBI-B)
The Cancer Behavior Inventory-Brief Version (CBI-B), a 12-item measure of self-efficacy for coping with cancer. Participants rate each item on how confident they are that they can do that behavior. Responses range from 1 to 9 with 1="Not at all confident", 5="Moderately Confident" and 9="Totally confident". Numbers in the middle of these cut points indicate somewhat confidence in performing these behaviors to a lesser or greater degree but are not specifically labelled. The total score is calculated by summing the scores for the 12 items for a total score range of 12-98, with higher scores indicating greater coping efficacy.
Measured: Up to 3 months
Change in score on the Functional Assessment of Cancer Therapy- General (FACT-G)
The FACT-G is a 27-item questionnaire designed to measure four domains of health related quality of life (HRQOL) in cancer patients with 4 domains of interest: Physical, social, emotional, and functional well-being. Each item response score ranges from 0 (not at all) to 5 (very much). The total score is a sum of the subscale scores, with a range from 0 - 108. The higher the score, the better the HRQOL.
Measured: Up to 3 months
Change in scores on the Quality of Life question
This is a single-item question, "How would you rate your overall quality of life?" with responses ranging from a scale of 1 to 10 with greater scores indicating a greater quality of life. This is a validated measure used currently in the SMS.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start26 Jan 2021
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Cheng, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697524
- Sponsor's protocol ID
- 20806
- Other IDs
- NCI-2020-11397
- Status last verified
- Aug 2023
- First submitted
- 5 Jan 2021
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- 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 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Palliative Care/Psycho-Oncology Telehealth Group Medical Visits for Patients With Advanced Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT04697524
- Acronym / sponsor ID
- 20806
- Conditions
- Advanced Malignant Solid Neoplasm, Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm
- Keywords
- Telehealth, Palliative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 6 Jan 2021 (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 trial investigates whether a joint and integrative approach to cancer care using palliative care and psycho-oncology is possible, and if it's beneficial to patients with cancer that has spread to other places on the body (advanced). The information gained from this study may help patients to learn about the medicinal and non-medicinal strategies to cope with their symptoms and side effects of their diagnosis and treatment while receiving peer support, in addition to standard individualized medical care.
Detailed description
PRIMARY OBJECTIVES:
- To develop and refine a joint Integrative Palliative Care/Psycho-oncology telehealth group medical visit (GMV) intervention based on feedback from an open pilot study with patient exit interviews.
II. To determine the feasibility and acceptability of the telehealth GMVs in a separate, single-arm pilot evaluation among patients with advanced cancer.
SECONDARY OBJECTIVE:
- To estimate the preliminary efficacy of the GMVs among patients with advanced cancer.
EXPLORATORY OBJECTIVES:
- To assess the financial viability of the GMVs. II. To measure the utilization of other supportive care services at Helen Diller Family Comprehensive Cancer Center (HDFCCC) and the Osher Center 3 months post-treatment.
III. To measure the University of California San Francisco (UCSF) healthcare utilization of participants 3 months post treatment.
OUTLINE:
PHASE I: The group-based intervention is developed, tested, and continuously refined based on participant feedback. Within 14 days of the first weekly group intervention, patients complete baseline questionnaires over 30-45 minutes about their sleep habits, pain management, anxiety/depression, and other symptoms. Patients then participate in a telehealth group medical intervention program over 2 hours weekly for up to 4 sessions where they review topics specific to managing fatigue and sleep habits, managing pain, managing emotional distress, and managing other symptoms and advanced care planning. During the weekly sessions, patients have the opportunity to meet with their symptom management service (SMS) provider in a separate virtual space for individual consultation over 5 minutes to discuss symptoms that they do not feel comfortable sharing in the larger group. The SMS provider may recommend specific interventions or resources for patients to discuss with their oncology, primary care, integrative medicine, psycho-oncology, or palliative care providers as appropriate. Patients also participate in an exit interview over 30 minutes to 1 hour.
PHASE II: Based on the feedback given in the first phase, three new cohorts of participants are recruited to assess the acceptability and feasibility of the refined intervention using similar procedures as in Phase I.
After completion of study, patients are followed up at 7 and 14 days, and then up to 3 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Supportive care (GMV) | Experimental | Behavioral: Support Group Therapy, Behavioral: Symptom Management Service (SMS) Consultation, Other: Quality of Life (QOL) Questionnaires, Other: InterviewParticipants will take a baseline assessment to collect socio-demographic information and complete a series of patient-reported outcome assessments (PROs) prior to their first group medical visit (GMV). The GMV intervention will take place over four weekly sessions conducted virtually. At the completion of all four weekly GMV sessions, participants will be asked to complete an exit survey. Participants in phase one will not be contacted or followed after the exit survey. |
| Phase 2: Refined GMV | Experimental | Behavioral: Support Group Therapy, Behavioral: Symptom Management Service (SMS) Consultation, Other: Quality of Life (QOL) Questionnaires, Other: InterviewUp to three new cohorts of participants are recruited to assess the acceptability and feasibility of the refined intervention based on the results from the Phase 1 group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Carry a diagnosis of an advanced solid tumor cancer (locally advanced or metastatic, i.e., stage III or IV cancer)
- Be age >= 18 years
- Be able to speak and read English
- Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet (assessed by participant self-report)
- Be capable of independently utilizing an online platform for telehealth group medical visits in a private setting (assessed by participant self-report)
Key exclusion criteria (4 listed)
- Have a cognitive or psychiatric condition prohibiting study consent or participation determined by co-principal investigators (PIs) or referring provider
- Be too medically unstable (or expected to become so during the study period) to participate in a telehealth group medical visit determined by co-PIs or referring providers
- Does not have insurance coverage for telehealth group medical visits
- Have extensive hearing loss such that ability to participate in the study would be impaired as determined by co-PIs or referring provider
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 |
|---|---|---|
| Support Group TherapyAlso: Virtual Visit, TelehealthVirtual group meetings | Behavioural | Phase 1: Supportive care (GMV), Phase 2: Refined GMV |
| Symptom Management Service (SMS) ConsultationAlso: SMS, Virtual VisitVirtual individual meetings with symptom management service (SMS) over 5 minutes | Behavioural | Phase 1: Supportive care (GMV), Phase 2: Refined GMV |
| Quality of Life (QOL) QuestionnairesAdministered at each study visit | Other | Phase 1: Supportive care (GMV), Phase 2: Refined GMV |
| InterviewAlso: Virtual VisitVirtual exit interview at end of study | Other | Phase 1: Supportive care (GMV), Phase 2: Refined GMV |
Primary outcome
Develop Categories for intervention refinement (Phase 1)
Time frame: Up to 3 months
Qualitative methods to analyze participant feedback obtained during exit interviews and code notes from by the existing domains: session relevance, delivery mode, ease of participation, suggested changes. A thematic content analysis will be performed to determine themes based on patterns and responses in these categories. Two coders will then meet to discuss the themes and reach agreement on final categories used to refine intervention for Phase 2 participants.
Proportion of participants enrolled
Time frame: 14 days
The proportion of eligible and approached patients who consent to participate.
Retention rate
Time frame: Up to 3 months
The percentage of patients who complete pre and post-treatment questionnaires.
Adherence rate
Time frame: Up to 3 months
Percentage of patients who complete 2 or more sessions. Will use one-sample negative binomial probability and tests of binomial proportions to compare rates of feasibility to hypothesized values.
Number of participants deemed ineligible or refusing to participate
Time frame: Up to 3 months
Number of participants who are determined to be ineligible before 1st virtual visit or refusal to participate before 1st visit and during treatment.
Frequency of Participant Ineligibility Reason
Time frame: Up to 14 days
For potential study candidates who are ineligible, we will log reasons for ineligibility
Frequency of Participant Refusal Reason
Time frame: Up to 14 days
For potential study candidates who decide not to participate, we will log reasons for refusal.
Mean post-treatment participant satisfaction ratings
Time frame: 1 day
Participant ratings on intervention convenience, helpfulness, recommendation to others, worth doing, and feeling connected with University of California, San Francisco (UCSF). Descriptive statistics (frequencies, means, and standard deviations (SDs)) and 95% confidence intervals will summarize patients' ratings
10 secondary outcomes
Change in distress score on the Edmonton Symptom Assessment System (ESAS)
Time frame: Up to 3 months
Change in scores on the Patient Health Questionnaire-8 (PHQ-8)
Time frame: Up to 3 months
Change in score on the Generalized Anxiety Disorder Assessment (GAD-7)
Time frame: Up to 3 months
Change in score on the Patient Reported Outcomes Measurement Information System-Cancer (PROMIS) Pain Interference- Short Form 4a
Time frame: Up to 3 months
Change in score on the PROMIS Sleep Disturbance- Short Form 6a
Time frame: Up to 3 months
Change in score on the PROMIS Fatigue - Short Form 6a
Time frame: Up to 3 months
Change in score on the PROMIS Social Isolation -Short Form 4a Short Form 4a
Time frame: Up to 3 months
Change in score on the Cancer Behavior Inventory-Brief (CBI-B)
Time frame: Up to 3 months
Change in score on the Functional Assessment of Cancer Therapy- General (FACT-G)
Time frame: Up to 3 months
Change in scores on the Quality of Life question
Time frame: Up to 3 months
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 15 Aug 2023.
- 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.
Stephanie Cheng, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Support Group Therapy, Symptom Management Service (SMS) Consultation and Quality of Life (QOL) Questionnaires in people with Advanced Malignant Solid Neoplasm and Locally Advanced Malignant Solid Neoplasm, run by University of California, San Francisco 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 7 inclusion and 4 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 15 Aug 2023. 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?
Develop Categories for intervention refinement (Phase 1) (time frame: Up to 3 months). The study lists 8 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 15 Aug 2023.