Efficacy of Stress Management Program for Depressive Patients with Advanced Head and Neck Cancer: an open-label randomized controlled trial

Efficacy of Stress Management Program for Depressive Patients with Advanced Head and Neck Cancer: an open-label randomized controlled trial - Stress Management Program for Patients with Advanced Head and Neck Cancer (SMAP-HNC study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018900

Enrollment

140

Registered

2015-11-02

Start date

2016-01-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with advanced head and neck cancer after initial curative treatment

Interventions

Intervention: The program, which was based a problem solving training for head and neck cancer patients and stress coping training for HIV patients, was developed by three clinical psychologists, a

Stress Management Program for Patients with Advanced Head and Neck Cancer (SMAP-HNC)&quot

. SMAP-HNC is conducted by clinical psychologist with a master degree. The session takes 90 minutes at the time of hospital discharge and the follow-up session takes 30 minutes at the first outpatient

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Who has larynx, epipharynx, oropharynx, hypopharynx, and/or oral cancer (2)Who has a diagnosis of squamous cell cancer (SCC) (3)Who has stage III or IV cancer (4)Who is admitted patient after initial radiation or operation therapy (5)Who is over 20 years old and under 80 years old (6)Who has depression (HADS total score >=11)

Exclusion criteria

Exclusion criteria: Who cannot participate the intervention or answer the questionnaire because of his/her physical, mental, or cognitive function.

Design outcomes

Primary

Measure	Time frame
Change in total score of Hospital Anxiety and Depression Scale (HADS) from the time of hospital discharge to the first outpatient visit	—

Secondary

Measure	Time frame
Change in total score of HADS from the time of hospital discharge to the 3 months after the intervention Change in each factor's score of HADS Change in each factor's score of Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Change in each factor's score of Head and Neck Cancer Inventory (HNCI) Change in each factor's score of Brief Coping Inventory (COPE) Change in total score of The Athens Insomnia Scale (AIS)	—

Measure

Time frame

Change in total score of HADS from the time of hospital discharge to the 3 months after the intervention Change in each factor's score of HADS Change in each factor's score of Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-H&N) Change in each factor's score of Head and Neck Cancer Inventory (HNCI) Change in each factor's score of Brief Coping Inventory (COPE) Change in total score of The Athens Insomnia Scale (AIS)

—

Countries

Japan

Contacts

Public ContactKanako Ichikura

Medical Hospital, Tokyo Medical and Dental University Department of Psychosomatic and Palliative Medicine

ichikura-creha@umin.ac.jp03-5803-5859

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026