Return to Work and Living Healthy After Head and Neck Cancer (RELIANCE)

University of Leipzig

Status: Terminated

Conditions: Head and Neck Cancer

Treatments: Behavioral: Return to work and living healthy after head and neck cancer; Behavioral: socio-legal counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT03065634

93000-133

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

39 participants in 2 patient groups

Manualized RELIANCE intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Return to work and living healthy after head and neck cancer

Non-manualized socio-legal counseling

Active Comparator group

Description:

two socio-legal counseling sessions delivered by a social worker

Treatment:

Behavioral: socio-legal counseling