CancerNCT03952312
Oncotool for Cancer Medications
A study testing Oncotool Intervention (symptom reporting + TKI education) in people with Cancer and Cancer, Treatment-Related, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to examine the efficacy of a psychosocial eHealth intervention on the proposed primary outcomes, TKI adherence and health related quality of life (HRQoL), in patients taking TKIs for cancer management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Cancer, Treatment-Related, Medication Adherence
- What is being tested?
- Oncotool Intervention (symptom reporting + TKI education)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2020to 4 Nov 2022
- 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
- ≥ 18 years of age
- medical chart confirmed diagnosis of cancer
- willingness to be randomized into study
- have initiated TKIs within the past 18 months, as data in literature indicates that the majority of patients who initiate oral anticancer medications are still adherent within the first few months
- willing to use a web-based platform on a bi-weekly basis, as well as an email address and access to the internet
- English speaking, as all material will be in English
Who cannot join
- significant cognitive impairment, inpatient psychiatric treatment, or overt signs of severe psychopathology (e.g., psychosis).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of OncoTool to Improve Self-Management and Adherence to Oral Anticancer Medications
The purpose of this study is to examine the efficacy of a psychosocial eHealth intervention on the proposed primary outcomes, TKI adherence and health related quality of life (HRQoL), in patients taking TKIs for cancer management.
The intervention components include psychosocial management strategies, cancer medication knowledge and embedded physician reports. The intervention will be delivered via an online application over an 8-week period. Participants in the intervention will complete bi-weekly side effect questionnaires as part of their study involvement, which may trigger an alert to their prescribing physician if they reach a certain threshold. Participants in the control will not complete these questionnaires.
Participants are randomized into either an intervention application (described above) or a control application (health information and general health promotion strategies). Aside from having access to the online application for the recommended 8 weeks, participation in this study includes three assessments: baseline (at the beginning of the research study), post-intervention (8 weeks after baseline) and a 6-month follow-up.
Read the detailed description
Molecularly targeted tyrosine kinase inhibitors (TKIs) have improved the overall prognosis of patients with cancer. When properly adhered to, TKIs can extend progression-free survival by decades. Despite the promise of TKIs, nonadherence is problematic and studies report that as little as 23% of patients are fully adherent over time. Poor adherence is of significance as it is associated with disease progression and mortality. Despite the importance of optimal adherence (<90% adherence for TKIs), only a handful of interventions with very limited documented efficacy have targeted adherence to TKIs. This is problematic as the number of patients receiving oral anticancer medications is steadily increasing and patients taking TKIs are required to be adherent for years to impact survival. Furthermore, the limited half-life of TKIs highlights the need to optimize full adherence to these medications.
The few interventions that have sought to improve oral anticancer medication adherence have been limited by: (a) lack of a conceptual model that incorporates modifiable psychosocial factors (e.g., illness perceptions, self-efficacy) known to influence adherence behaviors, (b) lack of patient-centered education and training to manage the chronic and debilitating burden of the medication side effects, and (c) lack of more than one objective method of tracking participants' medication adherence. Strategies that (a) facilitate patient-provider communication about side effects and side effect monitoring, and (b) incorporate evidence-based tools to improve side effect monitoring and management, as well as coping with illness-related stress, may be especially beneficial for aiding patients to optimally adhere to TKI medications. Therefore, the investigators propose that an evidence-based psychosocial intervention that can improve management of oral anticancer medication side effects, and therefore improve quality of life, may also improve adherence.
Previous work elucidating the determinants of adherence to oral anticancer medications and developing web-based symptom monitoring tools and psychosocial interventions for patients with cancer makes the research team uniquely positioned to develop and evaluate the feasibility of an intervention to improve adherence to life-saving TKI medications. Consistent with PA-17-061 (Oral Anticancer Agents), the investigators propose to establish the feasibility of an evidence-based, web-delivered and adaptive program called Oncotool to improve adherence to TKIs. Oncotool is patient centered and grounded in models of health behavior change, self-management and established barriers (e.g., patient, system and treatment factors) to medication adherence. Oncotool will incorporate patient education (e.g., compliance education, medication adherence benefits), track side effects bi-weekly, notify providers of patient-reported side effects, and provide medical and psychosocial management strategies for TKI medication side effects. The purpose of this study is to compare the efficacy of Oncotool to a control program, which will contain general health information such as cancer screening, diet and physical activity. The primary study outcome will be feasibility of Oncotool (i.e., acceptability, demand, practicality). Adherence and health-related quality of life (HRQoL) will be assessed as secondary outcomes over 6 months in Oncotool compared to the control condition.
- Conditions
- Cancer, Cancer, Treatment-Related, Medication Adherence, Communication, Tyrosine Kinase Inhibitor
- Being tested
- Oncotool Intervention (symptom reporting + TKI education), Oncotool Control (health information)
- Keywords
- eHealth, Adherence, Symptom Burden, Health Related Quality of Life
- Medical subject headings
- Neoplasms, Neoplasms, Second Primary, Medication Adherence, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncotool Intervention (symptom reporting + TKI education)Behavioural
OncoTool is a website intended to improve self-management practices for helping cancer patients cope with side effects and improve health-related quality of life. OncoTool provides symptom education and management for dealing with the numerous physical and mental side effects associated with TKIs (e.g., fatigue, nausea, skin toxicity). OncoTool is a website designed to improve TKI adherence by improving quality of life and TKI associated symptom burden, as well as providing a portal for provider-patient communication via a bi-weekly health questionnaire. Both intervention and active comparator conditions are administered to participants for 8 weeks.
Oncotool Control (health information)Behavioural
OncoTool is a health promotion website with health education on subjects like nutrition and exercise specific to cancer patients, as well as general advice on lifestyle choices and prevention. The Oncotool control has similar TKI education content as the experimental content but without the side effect education or physician notification. Both intervention and active comparator conditions are administered to participants for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| "OncoTool" Intervention | Experimental | Not described Receives: Behavioral: Oncotool Intervention (symptom reporting + TKI education) |
| "Oncotool" Control | Active comparator | Not described Receives: Behavioral: Oncotool Control (health information) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self Reported Adherence to TKIs will be evaluated with the ARMS questionnaire.
The ARMS (Adherence to Refills and Medications Scale) survey is a previously validated patient-report measure of barriers to medication adherence and adherence-related behavior.
Measured: Time Frame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention)
Electronically Verified TKI Adherence will be measured using medication event monitoring systems (MEMS)
A MEMS cap is an electronic bottle cap that tracks when participants open their medication bottle. MEMS cap data will be collected continuously during the duration of participation in the study.
Measured: ime Frame: MEMS data will be collected continuously during study participation from T1 (prior to starting intervention) to T3 (6 months post-intervention)
Pharmacy reported Adherence to TKIs will be measured using pharmacological records
Pharmacy data will be pulled once at approximately T3 when a participant finishes the study. This data will inform how frequently patients refill their oral cancer medication (TKIs).
Measured: T3 (6 months post-intervention)
Change in Health Related Quality of Life will be evaluated with The Functional Assessment of Cancer Therapy (FACT-G7)
The FACT-G7 is a validated questionnaire that assesses top-rated symptoms and concerns for a broad spectrum of advanced cancers.
Measured: T1 (prior to starting intervention), biweekly during the 8 week intervention, T2 (8 weeks post intervention), T3 (6 months post-intervention)
Secondary outcomes (7)
Cancer-Specific Distress will be evaluated using The Impact of Event Scale (IES)
The IES is made up of two subscales measuring the frequency of intrusion and avoidance experiences after a stressful event. The IES has been widely used among patients diagnosed with cancer.
Measured: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention)
Stress Management Skills will be evaluated with the Brief COPE Inventory
The Brief COPE is made up of various subscales measuring different ways of coping. Each question as participants to rate how often they have used each coping mechanism in response to their cancer experience.
Measured: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention)
Perceived benefits and cost barriers to using oral cancer medications will be assessed using a Beliefs about Medicines scale
The 11 point Beliefs about Medicines questionnaire assesses patients' beliefs about the efficacy of their treatment as well as their beliefs about how the benefits and side affects of oral cancer medications affect their life.
Measured: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention)
Emotional Social Support is assessed using the emotional subscale portion of the Medical Outcomes Study - Social Support Survey Instrument (MOS-SSS)
The 8 question MOS-SSS scale was developed by RAND Healthcare to assess the degree of companionship, assistance, or other types of social support that participants have access to. This study will use the 8 question emotional-informational support subsection.
Measured: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention)
Patient Self-Efficacy in managing side effects is measured using the PROMIS Self Efficacy for Managing Symptoms
The PROMIS Self Efficacy for Managing Symptoms survey is a validated, computer adaptive survey to assess how confident participants are in their ability to manage their symptoms and side effects
Measured: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention)
Cancer Related Communication and Attitudinal Self Efficacy will be evaluated using the Communication and Attitudinal Self-Efficacy scale for cancer (CASE-cancer)
The CASE-cancer questionnaire is made up various subscales measuring cancer related communication and attitudinal self-efficacy. Each question asks participants to use a four-point response scale to agree or disagree with statements regarding their level of confidence with different skills.
Measured: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention)
TKI specific side effects will be evaluated using measures from PRO-CTCAE
PRO-CTCAE is a patient-reported outcome measurement system developed by the National Cancer Institute to capture symptomatic adverse events in patients on cancer clinical trials. Measures specific to reported TKI side effects have been chosen for this study.
Measured: T1 (prior to starting intervention), bi-weekly during the 8 week intervention,.T2 (8 weeks post intervention), T3 (6 months post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start15 Jan 2020
- Primary completion13 Aug 2022
- Study completion4 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betina Yanez, Northwestern University
- Investigators
- Betina Yanez, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952312
- Sponsor's protocol ID
- STU00207397
- Status last verified
- Jan 2023
- First submitted
- 14 May 2019
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with any researchers outside Northwestern.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of OncoTool to Improve Self-Management and Adherence to Oral Anticancer Medications
- ClinicalTrials.gov ID
- NCT03952312
- Acronym / sponsor ID
- STU00207397
- Conditions
- Cancer, Cancer, Treatment-Related, Medication Adherence, Communication, Tyrosine Kinase Inhibitor
- Keywords
- eHealth, Adherence, Symptom Burden, Health Related Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 13 Aug 2022 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 16 May 2019 (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 examine the efficacy of a psychosocial eHealth intervention on the proposed primary outcomes, TKI adherence and health related quality of life (HRQoL), in patients taking TKIs for cancer management.
The intervention components include psychosocial management strategies, cancer medication knowledge and embedded physician reports. The intervention will be delivered via an online application over an 8-week period. Participants in the intervention will complete bi-weekly side effect questionnaires as part of their study involvement, which may trigger an alert to their prescribing physician if they reach a certain threshold. Participants in the control will not complete these questionnaires.
Participants are randomized into either an intervention application (described above) or a control application (health information and general health promotion strategies). Aside from having access to the online application for the recommended 8 weeks, participation in this study includes three assessments: baseline (at the beginning of the research study), post-intervention (8 weeks after baseline) and a 6-month follow-up.
Detailed description
Molecularly targeted tyrosine kinase inhibitors (TKIs) have improved the overall prognosis of patients with cancer. When properly adhered to, TKIs can extend progression-free survival by decades. Despite the promise of TKIs, nonadherence is problematic and studies report that as little as 23% of patients are fully adherent over time. Poor adherence is of significance as it is associated with disease progression and mortality. Despite the importance of optimal adherence (<90% adherence for TKIs), only a handful of interventions with very limited documented efficacy have targeted adherence to TKIs. This is problematic as the number of patients receiving oral anticancer medications is steadily increasing and patients taking TKIs are required to be adherent for years to impact survival. Furthermore, the limited half-life of TKIs highlights the need to optimize full adherence to these medications.
The few interventions that have sought to improve oral anticancer medication adherence have been limited by: (a) lack of a conceptual model that incorporates modifiable psychosocial factors (e.g., illness perceptions, self-efficacy) known to influence adherence behaviors, (b) lack of patient-centered education and training to manage the chronic and debilitating burden of the medication side effects, and (c) lack of more than one objective method of tracking participants' medication adherence. Strategies that (a) facilitate patient-provider communication about side effects and side effect monitoring, and (b) incorporate evidence-based tools to improve side effect monitoring and management, as well as coping with illness-related stress, may be especially beneficial for aiding patients to optimally adhere to TKI medications. Therefore, the investigators propose that an evidence-based psychosocial intervention that can improve management of oral anticancer medication side effects, and therefore improve quality of life, may also improve adherence.
Previous work elucidating the determinants of adherence to oral anticancer medications and developing web-based symptom monitoring tools and psychosocial interventions for patients with cancer makes the research team uniquely positioned to develop and evaluate the feasibility of an intervention to improve adherence to life-saving TKI medications. Consistent with PA-17-061 (Oral Anticancer Agents), the investigators propose to establish the feasibility of an evidence-based, web-delivered and adaptive program called Oncotool to improve adherence to TKIs. Oncotool is patient centered and grounded in models of health behavior change, self-management and established barriers (e.g., patient, system and treatment factors) to medication adherence. Oncotool will incorporate patient education (e.g., compliance education, medication adherence benefits), track side effects bi-weekly, notify providers of patient-reported side effects, and provide medical and psychosocial management strategies for TKI medication side effects. The purpose of this study is to compare the efficacy of Oncotool to a control program, which will contain general health information such as cancer screening, diet and physical activity. The primary study outcome will be feasibility of Oncotool (i.e., acceptability, demand, practicality). Adherence and health-related quality of life (HRQoL) will be assessed as secondary outcomes over 6 months in Oncotool compared to the control condition.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "OncoTool" Intervention | Experimental | Behavioral: Oncotool Intervention (symptom reporting + TKI education) |
| "Oncotool" Control | Active comparator | Behavioral: Oncotool Control (health information) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 18 years of age
- medical chart confirmed diagnosis of cancer
- willingness to be randomized into study
- have initiated TKIs within the past 18 months, as data in literature indicates that the majority of patients who initiate oral anticancer medications are still adherent within the first few months
- willing to use a web-based platform on a bi-weekly basis, as well as an email address and access to the internet
Key exclusion criteria (1 listed)
- significant cognitive impairment, inpatient psychiatric treatment, or overt signs of severe psychopathology (e.g., psychosis).
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 |
|---|---|---|
| Oncotool Intervention (symptom reporting + TKI education)OncoTool is a website intended to improve self-management practices for helping cancer patients cope with side effects and improve health-related quality of life. OncoTool provides symptom education and management for dealing with the numerous physical and mental side effects associated with TKIs (e.g., fatigue, nausea, skin toxicity). OncoTool is a website designed to improve TKI adherence by improving quality of life and TKI associated symptom burden, as well as providing a portal for provider-patient communication via a bi-weekly health questionnaire. Both intervention and active comparator conditions are administered to participants for 8 weeks. | Behavioural | "OncoTool" Intervention |
| Oncotool Control (health information)OncoTool is a health promotion website with health education on subjects like nutrition and exercise specific to cancer patients, as well as general advice on lifestyle choices and prevention. The Oncotool control has similar TKI education content as the experimental content but without the side effect education or physician notification. Both intervention and active comparator conditions are administered to participants for 8 weeks. | Behavioural | "Oncotool" Control |
Primary outcome
Change in Self Reported Adherence to TKIs will be evaluated with the ARMS questionnaire.
Time frame: Time Frame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention)
The ARMS (Adherence to Refills and Medications Scale) survey is a previously validated patient-report measure of barriers to medication adherence and adherence-related behavior.
Electronically Verified TKI Adherence will be measured using medication event monitoring systems (MEMS)
Time frame: ime Frame: MEMS data will be collected continuously during study participation from T1 (prior to starting intervention) to T3 (6 months post-intervention)
A MEMS cap is an electronic bottle cap that tracks when participants open their medication bottle. MEMS cap data will be collected continuously during the duration of participation in the study.
Pharmacy reported Adherence to TKIs will be measured using pharmacological records
Time frame: T3 (6 months post-intervention)
Pharmacy data will be pulled once at approximately T3 when a participant finishes the study. This data will inform how frequently patients refill their oral cancer medication (TKIs).
Change in Health Related Quality of Life will be evaluated with The Functional Assessment of Cancer Therapy (FACT-G7)
Time frame: T1 (prior to starting intervention), biweekly during the 8 week intervention, T2 (8 weeks post intervention), T3 (6 months post-intervention)
The FACT-G7 is a validated questionnaire that assesses top-rated symptoms and concerns for a broad spectrum of advanced cancers.
7 secondary outcomes
Cancer-Specific Distress will be evaluated using The Impact of Event Scale (IES)
Time frame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention)
Stress Management Skills will be evaluated with the Brief COPE Inventory
Time frame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention)
Perceived benefits and cost barriers to using oral cancer medications will be assessed using a Beliefs about Medicines scale
Time frame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention)
Emotional Social Support is assessed using the emotional subscale portion of the Medical Outcomes Study - Social Support Survey Instrument (MOS-SSS)
Time frame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention)
Patient Self-Efficacy in managing side effects is measured using the PROMIS Self Efficacy for Managing Symptoms
Time frame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention)
Cancer Related Communication and Attitudinal Self Efficacy will be evaluated using the Communication and Attitudinal Self-Efficacy scale for cancer (CASE-cancer)
Time frame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention)
TKI specific side effects will be evaluated using measures from PRO-CTCAE
Time frame: T1 (prior to starting intervention), bi-weekly during the 8 week intervention,.T2 (8 weeks post intervention), T3 (6 months post-intervention)
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 26 Jan 2023.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with any researchers outside Northwestern.
Related trials for Cancer
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
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 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
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.
Betina Yanez principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oncotool Intervention (symptom reporting + TKI education) in people with Cancer and Cancer, Treatment-Related, run by Northwestern University 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 6 inclusion and 1 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 26 Jan 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?
Change in Self Reported Adherence to TKIs will be evaluated with the ARMS questionnaire. (time frame: Time Frame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention)). 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 26 Jan 2023.