Please select the eligibility criteria that correspond to the clinical trial below.
Title: Impact of a Group Intervention on Breast Cancer Patient's Adjustment and Emotion Regulation at the End of Treatment
Brief Summary: Background: The end of treatment is for cancer patients the beginning of a critical rehabilitation period including numerous physical, emotional, professional and cognitive challenges. Specific interventions adapted to this post-treatment period need thus to be designed. Interventions such as group cognitive-behavioral therapy and hypnosis have been shown to be effective. However, moderate effect sizes, no comprehensive description of the treatment interventions and assessments relying only on self-report measures warrant further investigation. This study aims to assess, in breast cancer patients at the end of treatment, the impact of a group intervention combining cognitive-behavioral therapy and hypnosis versus a group intervention on patient's adjustment and emotion self-regulation.

Design: This is a two-armed, longitudinal, randomized controlled trial. Breast cancer patients finishing their radiation therapy treatment will be randomized to either an immediate group intervention combining cognitive-behavioral therapy and hypnosis or a group intervention. Patients will be assessed at three time points during the first year following the end of treatment: at 1 (T1), 6 (T2) and 12 (T3) months after the end of treatment. Patients' adjustment will be assessed through questionnaires. Patient emotion self-regulation ability will be assessed through their ability to respond both subjectively (self-reported emotional state) and objectively (heart rate) to two emotion self-regulation tasks.

Discussion: It is hypothesized that a group intervention combining cognitive-behavioral therapy and hypnosis will be more effective than a group intervention. Results of this study will contribute to improving post-treatment care for breast cancer patients.


Options:
A: Inclusion Criteria

* Patients with a verified cancer diagnosis other than basal cell carcinoma, incl. H\&N cancer
* Sufficient language ability to understand and complete the questionnaires without assistance
* No obvious cognitive impairments, as judged by the study coordinator upon inclusion
* Age 18 years or above
* Provision of written informed consent
* No participation in another trial or study possibly interfering with the present study

Exclusion Criteria:

* Patients being diagnosed with basal cell carcinoma
* Patients who have been included in Phase I-III of the module development
* Patients who are in the terminal phase of cancer
* Patients who are unable to participate in the interviews do to obvious cognitive impairment, psychological disturbance or language problems
B: Inclusion Criteria:

* 21 years old or older
* Diagnosed with Stage 0, I, II, or III breast cancer
* Undergone lumpectomy and completed adjuvant radiation and/or chemotherapy (end of treatment to 18 months post-treatment)
* Ability to read and speak English at the 8th grade level to respond to the survey questions

Exclusion Criteria:

* Advanced stage (IV) breast cancer
* History of mastectomy
* Current psychiatric diagnosis
* Recurrent treatment for prior breast cancer
C: Inclusion Criteria:

* Clinical diagnosis of breast or prostate cancer
* Must be able to follow instructions
* Good cognitive ability
* Willing to participate

Exclusion Criteria:

* Use of cortisone
* Xerostomia
* oral mucositis
D: Inclusion Criteria:

* Non-metastatic breast cancer (in situ or invesive)
* End of active treatments (surgery, chemotherapy and radiotherapy)
* No recurrence nor palliative care
* Min. 18 years
* Able to speak French
* Willing to be randomized to study intervention group
* Accept to give their written informed consent

Exclusion Criteria:

* No cognitive dysfunction
* No severe or uncontrolled psychiatric illness

Answer: D