Head and Neck CancerRELIANCENCT03065634
Return to Work and Living Healthy After Head and Neck Cancer
A study testing Return to work and living healthy after head and neck cancer and socio-legal counseling in people with Head and Neck Cancer, run by University of Leipzig at 1 site in Germany.
Trial summary
Based on a randomized controlled trial, the manualized group intervention Return to work and living healthy after head and neck cancer (RELIANCE) for head and neck cancer survivors will be tested against a non-manualized control intervention (social counseling) in order to evaluate the efficacy of the RELIANCE… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Return to work and living healthy after head and neck cancer and socio-legal counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2017to 31 Dec 2018
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of laryngea, hypopharyngeal, oropharyngeal, tonsil or base of the tongue cancer within the last six months
- Curative treatment
- Completion of primary and follow-up Treatment
- Fluency in German
- Written informed and voluntary consent
- Psychological distress (Distress Thermometer score > 4)
- Self-perceived prognosis of employment (SPE score ≥ 1)
Who cannot join
- Alcohol dependency with physical withdrawal symptoms (CAGE score ≥ 3 and current use of alcohol)
- Acute suicidal tendencies
- Receiving old-age pension or will receive old-age pension within the next 12 months
- Cognitive impairment indicated in the medical records or by the attending doctor
- Being in psychotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Based on a randomized controlled trial, the manualized group intervention Return to work and living healthy after head and neck cancer (RELIANCE) for head and neck cancer survivors will be tested against a non-manualized control intervention (social counseling) in order to evaluate the efficacy of the RELIANCE intervention compared to the control condition. The study design includes two phases, the initial study phase (pilot study) and the intervention study (RCT). The aim of the pilot study is to implement and ensure the necessary standardized procedures for the implementation of patient recruitment and interventions. In the randomized controlled trial, potential participants are assigned to the intervention group or to the control group.
- Conditions
- Head and Neck Cancer
- Being tested
- Return to work and living healthy after head and neck cancer, socio-legal counseling
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Return to work and living healthy after head and neck cancerBehavioural
Return to work and living healthy after head and neck cancer (RELIANCE) is a 2-months group intervention for head and neck cancer patients delivered by a trained psychotherapist and a peer in eight sessions. The individual sessions aim to improve work ability, quality of life and psychological well-being
socio-legal counselingBehavioural
Non-manualized socio-legal counseling
two socio-legal counseling sessions delivered by a social worker
| Study group | Role | What they receive |
|---|---|---|
| Manualized RELIANCE intervention | Experimental | Return to work and living healthy after head and neck cancer (RELIANCE) is a 2-months group intervention for head and neck cancer patients delivered by a trained psychotherapist and a peer in eight sessions. Receives: Behavioral: Return to work and living healthy after head and neck cancer |
| Non-manualized socio-legal counseling | Active comparator | two socio-legal counseling sessions delivered by a social worker Receives: Behavioral: socio-legal counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Work ability
Work-Ability-Index, short version (WAI)
Measured: directly after intervention and at six months follow-up
Pattern of work-related coping behaviour
Pattern of work-related coping behaviour, short Version (AVEM-44)
Measured: directly after intervention and at six months follow-up
Secondary outcomes (5)
Cancer-specific health-related quality of Life (global, functioning, symptom burden)
Quality of Life Core Questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC-QLQ-C30)
Measured: directly after intervention and at six months follow-up
Quality of life and symptoms specific to head and neck cancer
Head and Neck Module of the European Organisation for Research and Treatment of Cancer (EORTC-H\&N35)
Measured: directly after intervention and at six months follow-up
anxiety, depression and psychological distress in patients with somatic diseases
Hospital Anxiety and Depression Scale (HADS)
Measured: directly after intervention and at six months follow-up
health behavior and health related attitudes and knowledge about specific diseases
questionnaire measuring health behavior and health related attitudes and knowledge about specific diseases (FEG)
Measured: directly after intervention and at six months follow-up
general self-efficacy expectation
general self-efficacy expectation (ASKU)
Measured: directly after intervention and at six months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start1 Jan 2017
- Primary completion30 Sep 2018
- Study completion31 Dec 2018
Why it stopped: insufficient recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Leipzig, Jena University Hospital, Klinikum St. Georg gGmbH, Stadtisches Klinikum Dresden, German Cancer Aid
- Responsible party
- Principal investigator, Anja Mehnert, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065634
- Sponsor's protocol ID
- 93000-133
- Acronym
- RELIANCE
- Status last verified
- Nov 2020
- First submitted
- 17 Feb 2017
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Return to Work and Living Healthy After Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT03065634
- Acronym / sponsor ID
- RELIANCE / 93000-133
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment rate
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- Universitätsklinikum Leipzig, Jena University Hospital, Klinikum St. Georg gGmbH, Stadtisches Klinikum Dresden, German Cancer Aid
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 28 Feb 2017 (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.
Based on a randomized controlled trial, the manualized group intervention Return to work and living healthy after head and neck cancer (RELIANCE) for head and neck cancer survivors will be tested against a non-manualized control intervention (social counseling) in order to evaluate the efficacy of the RELIANCE intervention compared to the control condition. The study design includes two phases, the initial study phase (pilot study) and the intervention study (RCT). The aim of the pilot study is to implement and ensure the necessary standardized procedures for the implementation of patient recruitment and interventions. In the randomized controlled trial, potential participants are assigned to the intervention group or to the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manualized RELIANCE intervention | Experimental | Behavioral: Return to work and living healthy after head and neck cancerReturn to work and living healthy after head and neck cancer (RELIANCE) is a 2-months group intervention for head and neck cancer patients delivered by a trained psychotherapist and a peer in eight sessions. |
| Non-manualized socio-legal counseling | Active comparator | Behavioral: socio-legal counselingtwo socio-legal counseling sessions delivered by a social worker |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of laryngea, hypopharyngeal, oropharyngeal, tonsil or base of the tongue cancer within the last six months
- Curative treatment
- Completion of primary and follow-up Treatment
- Fluency in German
- Written informed and voluntary consent
Key exclusion criteria (5 listed)
- Alcohol dependency with physical withdrawal symptoms (CAGE score ≥ 3 and current use of alcohol)
- Acute suicidal tendencies
- Receiving old-age pension or will receive old-age pension within the next 12 months
- Cognitive impairment indicated in the medical records or by the attending doctor
- Being in psychotherapy
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 |
|---|---|---|
| Return to work and living healthy after head and neck cancerReturn to work and living healthy after head and neck cancer (RELIANCE) is a 2-months group intervention for head and neck cancer patients delivered by a trained psychotherapist and a peer in eight sessions. The individual sessions aim to improve work ability, quality of life and psychological well-being | Behavioural | Manualized RELIANCE intervention |
| socio-legal counselingNon-manualized socio-legal counseling two socio-legal counseling sessions delivered by a social worker | Behavioural | Non-manualized socio-legal counseling |
Primary outcome
Work ability
Time frame: directly after intervention and at six months follow-up
Work-Ability-Index, short version (WAI)
Pattern of work-related coping behaviour
Time frame: directly after intervention and at six months follow-up
Pattern of work-related coping behaviour, short Version (AVEM-44)
5 secondary outcomes
Cancer-specific health-related quality of Life (global, functioning, symptom burden)
Time frame: directly after intervention and at six months follow-up
Quality of life and symptoms specific to head and neck cancer
Time frame: directly after intervention and at six months follow-up
anxiety, depression and psychological distress in patients with somatic diseases
Time frame: directly after intervention and at six months follow-up
health behavior and health related attitudes and knowledge about specific diseases
Time frame: directly after intervention and at six months follow-up
general self-efficacy expectation
Time frame: directly after intervention and at six months follow-up
Results and safety
The study was stopped early (reason given: insufficient recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Related InfoLink provided by the sponsor.
- 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.
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 Return to work and living healthy after head and neck cancer and socio-legal counseling in people with Head and Neck Cancer, run by University of Leipzig at 1 site in Germany.
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 5 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: stopped early, as of the sponsor's last update on 5 Nov 2020. 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 Germany. 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 was stopped early (reason given: insufficient recruitment rate). Results are not available in the source record.
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?
Work ability (time frame: directly after intervention and at six months follow-up). The study lists 2 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 5 Nov 2020.