Distress in Caregivers of Cancer PatientsPhase 3PREPARENCT02739243
A Clinical Trial on a Group Treatment for Distressed Caregivers of Cancer Patients
A Phase 3 study testing Tailored group intervention (PREPARE) and Individual treatment as usual in people with Distress in Caregivers of Cancer Patients, run by Heidelberg University.
Trial summary
Background and study aims: Being a caregiver for someone with cancer can be very difficult emotionally. For many the patient is a family member or friend, and so this can cause the caregiver a great deal of psychological distress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distress in Caregivers of Cancer Patients
- What is being tested?
- Tailored group intervention (PREPARE) and Individual treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Oct 2016
- Phase
- Phase 3
- 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
- Time since initial diagnosis (of patient) not longer than six months previously
- Significant distress against the background of the cancer disease (QSC-R10C exceeding 16 points)
- Provision of informed consent
- Aged 18 or over, either gender
Who cannot join
- Inability to give informed consent
- Insufficient German language knowledge
- Cognitive impairment impeding handling of questionnaires
- Severe psychiatric disease (acute psychosis or acute suicidality)
About this study
Official title: Addressing the Hidden Patient - A Randomised-controlled Trial of a Tailored Group Intervention for Caregivers of Cancer Patients (PREPARE)
Background and study aims: Being a caregiver for someone with cancer can be very difficult emotionally. For many the patient is a family member or friend, and so this can cause the caregiver a great deal of psychological distress. There are currently very few studies looking into the effectiveness of psychological treatments for distressed caregivers of cancer patients. This study is looking at tailored group therapy program for carers of cancer givers. The aim of this study is to find out whether this program can help to lower levels of distress in cancer caregivers and help them to better cope with caring for someone with the illness.
- Being tested
- Tailored group intervention (PREPARE), Individual treatment as usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored group intervention (PREPARE)Behavioural
Individual treatment as usualBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Tailored group intervention | Experimental | Participants take part in the tailored group intervention which consists of five 90-minute group sessions over eight weeks. The sessions are in the form of structured group talk/discussions following specific themes:
Session 1 - Coping and acceptance: identification of common themes from participants' feedback, provision of information about support services, mindfulness practices
Session 2 - Distress: introduction of the distress model, identification of resources, breathing practices
Session 3 - Handling of stressful situations: individual identification in tandems, discussion of common pitfalls in the group
Session 4 - Self-care: inspection of individual daily routines, group collects positive experiences with "windows" for self-care
Session 5 - Feedback and outlook: stabilisation, retrospective reflection on the group experience and its benefits and, if applicable, potential adverse events Receives: Behavioral: Tailored group intervention (PREPARE) |
| Treatment as usual | Active comparator | Participants are provided with brief information in a leaflet, about the possibilities for individual counselling including referral to the local outpatient cancer counselling centre providing client-centred counselling and financial social work. Receives: Behavioral: Individual treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distress
measured using the Questionnaire on Stress in Caregivers of Cancer Patients Revised version (QSC-R10C)
Measured: change from baseline distress at 1 week post treatment
Secondary outcomes (7)
Depression
measured using the Patient Health Questionnaire-9 (PHQ-9)
Measured: change from baseline depression at 1 week post treatment and at 6 months post treatment
Anxiety
measured using the Generalized Anxiety Disorder-7 (GAD-7)
Measured: change from baseline anxiety at 1 week post treatment and at 6 months post treatment
General distress
measured using the Distress Thermometer (NCCN DT)
Measured: change from baseline general distress at 1 week post treatment and at 6 months post treatment
Unmet needs
measured using the Supportive Care Needs Survey - Partners \& Caregivers (SCNS-P\&C-G)
Measured: change from baseline unmet needs at 1 week post treatment and at 6 months post treatment
Self-efficacy in coping with the cancer disease
measured using the adapted General Perceived Self-Efficacy Scale
Measured: change from baseline self-efficacy at 1 week post treatment and at 6 months post treatment
Utilisation of primary healthcare
measured via the number of visits with the individual primary care physician
Measured: change from baseline to 1 week post treatment and 6 months post treatment
Positive bonding with the group
measured via the Positive Bonding Scale of the Group Questionnaire (GQ-D)
Measured: change from baseline bonding at 1 week post treatment and 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Enrolment slower than anticipated accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distress in Caregivers of Cancer PatientsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Markus Haun, Heidelberg University
- Investigators
- Markus W Haun, MD, Principal investigator, Department of General Internal Medicine and Psychosomatics, Heidelberg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739243
- Sponsor's protocol ID
- S-655/2015
- Other IDs
- ISRCTN22231701
- Acronym
- PREPARE
- Status last verified
- Oct 2016
- First submitted
- 7 Apr 2016
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing the Hidden Patient - A Randomised-controlled Trial of a Tailored Group Intervention for Caregivers of Cancer Patients (PREPARE)
- ClinicalTrials.gov ID
- NCT02739243
- Acronym / sponsor ID
- PREPARE / S-655/2015
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Enrolment slower than anticipated accrual.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 15 Apr 2016 (estimated)
- 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.
Background and study aims: Being a caregiver for someone with cancer can be very difficult emotionally. For many the patient is a family member or friend, and so this can cause the caregiver a great deal of psychological distress. There are currently very few studies looking into the effectiveness of psychological treatments for distressed caregivers of cancer patients. This study is looking at tailored group therapy program for carers of cancer givers. The aim of this study is to find out whether this program can help to lower levels of distress in cancer caregivers and help them to better cope with caring for someone with the illness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored group intervention | Experimental | Behavioral: Tailored group intervention (PREPARE)Participants take part in the tailored group intervention which consists of five 90-minute group sessions over eight weeks. The sessions are in the form of structured group talk/discussions following specific themes: Session 1 - Coping and acceptance: identification of common themes from participants' feedback, provision of information about support services, mindfulness practices Session 2 - Distress: introduction of the distress model, identification of resources, breathing practices Session 3 - Handling of stressful situations: individual identification in tandems, discussion of common pitfalls in the group Session 4 - Self-care: inspection of individual daily routines, group collects positive experiences with "windows" for self-care Session 5 - Feedback and outlook: stabilisation, retrospective reflection on the group experience and its benefits and, if applicable, potential adverse events |
| Treatment as usual | Active comparator | Behavioral: Individual treatment as usualParticipants are provided with brief information in a leaflet, about the possibilities for individual counselling including referral to the local outpatient cancer counselling centre providing client-centred counselling and financial social work. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Time since initial diagnosis (of patient) not longer than six months previously
- Significant distress against the background of the cancer disease (QSC-R10C exceeding 16 points)
- Provision of informed consent
- Aged 18 or over, either gender
Key exclusion criteria (4 listed)
- Inability to give informed consent
- Insufficient German language knowledge
- Cognitive impairment impeding handling of questionnaires
- Severe psychiatric disease (acute psychosis or acute suicidality)
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 |
|---|---|---|
| Tailored group intervention (PREPARE) | Behavioural | Tailored group intervention |
| Individual treatment as usual | Behavioural | Treatment as usual |
Primary outcome
Distress
Time frame: change from baseline distress at 1 week post treatment
measured using the Questionnaire on Stress in Caregivers of Cancer Patients Revised version (QSC-R10C)
7 secondary outcomes
Depression
Time frame: change from baseline depression at 1 week post treatment and at 6 months post treatment
Anxiety
Time frame: change from baseline anxiety at 1 week post treatment and at 6 months post treatment
General distress
Time frame: change from baseline general distress at 1 week post treatment and at 6 months post treatment
Unmet needs
Time frame: change from baseline unmet needs at 1 week post treatment and at 6 months post treatment
Self-efficacy in coping with the cancer disease
Time frame: change from baseline self-efficacy at 1 week post treatment and at 6 months post treatment
Utilisation of primary healthcare
Time frame: change from baseline to 1 week post treatment and 6 months post treatment
Positive bonding with the group
Time frame: change from baseline bonding at 1 week post treatment and 6 months post treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- Individual participant dataSharing planned: Undecided
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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.
Markus W Haun, MD principal investigator
Department of General Internal Medicine and Psychosomatics, Heidelberg University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tailored group intervention (PREPARE) and Individual treatment as usual in people with Distress in Caregivers of Cancer Patients, run by Heidelberg University.
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 4 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: withdrawn, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Distress (time frame: change from baseline distress at 1 week post treatment). 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 Oct 2016.