Behaviors and Mental Disorders

All Conditions

Symptoms and General Pathology

Neoplasms

Depression

Anxiety Disorders

Depressive Disorder

Pain

Head and Neck Neoplasms

Central Nervous System Stimulants

All Drugs and Chemicals

Analgesics

Anti-Infective Agents

Anti-Infective Agents, Local

Treatment as usual (TAU; i.e. pharmacological treatments and advices) + structured education + instructions on self care

Treatment as usual (TAU; i.e. pharmacological treatments and advices)

Six education areas was offered: pain and pain physiology, pain medication, side effects and prevention of side effects, abuse of medications, sleep advice and advice on anxiety.

Education

The following instructions on self-care for pain relief: apply ice or crushed ice in the oral cavity, lubricating and antiseptic mouth rinses, pain relieving gel, tongue movements and gaps exercises. Prevention of dryness in the mouth and throat; saliva stimulants and saliva substitute agents in different preparations, increased measures of good oral hygiene. Physical activities and regular rest once to several times per day. Sleep restriction and measures to treat sleep disorders.

Self Care

Treatment as usual (TAU)

Bjorn Gerdle, Professor MD

The purpose of this study is to evaluate the effect of individual education and individual self-care measures on pain intensity, perceived health, mood and sleep during and after treatment with radiotherapy for head and neck cancer.

The purpose of this study is to evaluate the effect of individual education and individual self-care measures on pain intensity, perceived health, mood and sleep during and after treatment with radiotherapy for head and neck cancer

All patients who referred to the Pain and Rehabilitation Centre at the University Hospital, asked about participation in the study. Of those who agreed to participate every second patient were distributed to the control group versus intervention group.

Pain Related to Head and Neck Cancer (HNC); Implementation and Evaluation of Self-care Measure Due to the Same Illness

Pain Related to Head and Neck Cancer (HNC); Implementation and Evaluation of Self-care Measure Due to the Same Illness During Radiotherapy (RT)

Pain intensity the actual day using a numeric rating scale.

Pain interference the actual day using a numeric rating scale

Perceived health according to the index based on five dimensions of European Quality of Life instrument (EQ-5D index)

Perceived health according to the visual analgue scale of European Quality of Life instrument (EQ-VAS)

Depression scale of Hospital and Depression Scale (HADS)

Anxiety scale of Hospital and Depression Scale (HADS)

Total score of Pain Catastrophizing scale

Linkoeping University

Professor MD

Skin and Connective Tissue Diseases

Nervous System Diseases

Fatigue

Breast Neoplasms

Pain, Postoperative

Breast Diseases

Skin Diseases

Postoperative Complications

Neurologic Manifestations

Single 20 minute medical hypnosis session delivered pre-surgery plus internet-based acceptance and commitment therapy delivered post-surgery

Single 20 minute mindfulness session delivered pre-surgery plus treatment as usual post-surgery

Single session 20 minutes hypnosis session originally developed and tested by Montgomery et al. (2007) in a similar setting. Delivered by an experienced clinical psychologist.

Medical hypnosis

Access to an online platform developed to this study containing video clips and audio files with ACT consistent material

Internet-based Acceptance and Commitment Therapy (iACT)

Single session mindfulness session delivered by audio file

Mindfulness session

Treatment as usual as part of post-surical care

Treatment as Usual (TAU)

Silje E Reme, PhD

Henrik B Jacobsen, PhD

The study aims to investigate whether a combined pre-operative medical hypnosis plus a post-operative internet-based acceptance and commitment intervention are more effective in preventing post-surgical pain and fatigue following breast cancer surgery compared with pre-operative mindfulness plus treatment as usual.

The trial will include 200 patients undergoing breast cancer surgery at Oslo University Hospital. The patients will be randomized into two groups. One group will receive a 20 minute pre-surgical hypnosis session delivered by an experienced clinical psychologist plus a post-surgical internet-based acceptance and commitment intervention. The control group will receive a 20 minute pre-surgical mindfulness session delivered through an audio recording plus treatment as usual. The primary outcomes of the study are quantitative measures of post-surgical pain and fatigue. In addition, relationships between biomarkers of stress and subacute post-surgical pain and fatigue will be analyzed using using blood- and hair samples. The study uses a longitudinal design with baseline measures obtained pre-surgery and follow up measures obtained 3 and 12 months post-surgery.

Randomized Controlled Trial, in which participants are randomly allocated to either the intervention group or an active control group.

The intervention group vs. active control group status will be known to the participants and the health care personnel delivering the interventions. However, the investigator, outcome assessor and the additional health care personnel at the unit will be masked to the conditions.

Eligible participants are women (biological sex) diagnosed with breast cancer

Psychological Interventions to Prevent Late Effects in Breast Cancer

Pre- and Post-operative Psychological Interventions to Prevent Pain and Fatigue After Breast Cancer Surgery: a Randomized Controlled Trial

The study protocol, along with the intervention protocols, will all be published and publicly available. Registry data will not be shared as this is not allowed to share according to Norwegian law. However, data files involving questionnaire and biomarker data will be made available upon reasonable request. Due to privacy concerns, the complete data files will not be shared online.

Measured through a Numeric Rating Scale (NRS) for pain intensity. The scale ranges from 0-10, anchored by verbal descriptors at either end of the scale where 0 is no pain at all and 10 is the worst possible pain.

Measured through the 13-item Functional Assessment of Chronic Illness Therapy-Fatigue subscale (FACIT-F) which is a unidimensional self-report scale to assess fatigue and its impact on daily life. The score range is 0-52 where a higher score indicates better quality of life (i.e. less symptoms and disability)

Measured by a Visual Analogue Scale (VAS) (to replicate a previous hypnosis trial - Montgomery et al 2007). The range is 0-100 where a higher score indicates more intense symptoms.

Immune function is assessed through whole blood samples using the standardized TruCulture system that contains immunogenic stimuli (infected tubes). This test will reveal the induced innate and adaptive immune response in whole blood after stimulation with LPS, by quantifying the release of soluble immune activation products (cytokines, chemokines, soluble receptors etc.) in the supernatant and by measuring the transcription level (mRNA) in the circulating blood (immune) cells.

Usage of psychotropic and pain medication obtained through registry data from the Norwegian Prescription Database at 3 and 12 months follow-up. Number of prescriptions will be summarized and compared between intervention and control group.

Days away from work on sick leave will be measured through registry data

Measured through the Acceptance and Action Questionnaire (AAQ-II). The scale ranges from 7-49, where higher score indicates more psychological inflexibility

Measured through the Hospital Anxiety and Depression Scale (HADS). The total score ranges from 0-42, where a higher score indicates more symptoms

Oslo University Hospital

University of Oslo

Professor

Participant will receive a 2-hour interventional session. Its content will consist of two modules: (1) psychoeducation and coping, providing information in content areas such as side effects of cancer treatments, fever protocols, role disruption and (2) stress, triggers, and self care, where caregivers will be briefed on symptoms of and reactions to traumatic stress in order to help parents accurately label thoughts and emotions related to their child's cancer diagnosis.

Participant will receive a 2-hour interventional session

GOLD Program

Participant will receive treatment-As-Usual which consist of information about diagnosis routinely-disseminated by personnel and providers.

Victoria E. Cosgrove, PhD

Sheri Spunt, MD

The purpose of this study is to examine a psychotherapeutic and psycho-educational intervention offered in virtual settings to caregivers of youth with cancer. Human subjects must be used because they are the object of the intervention.

PRIMARY OBJECTIVE(S)- To examine the feasibility and accessibility of a brief intervention for caregivers of youth with newly-diagnosed cancer as a preliminary, data-generating step toward applying for a larger NCI R34 grant evaluating the efficacy of the program in a randomized controlled trial.

SECONDARY OBJECTIVE(S)- We hope to learn whether a psycho-educational, psychotherapeutic intervention offered in a virtual setting to caregivers of children diagnosed with cancer is feasible, is acceptable, and can prevent, minimize, or improve symptoms of psychological distress (including symptoms of anxiety, depression, and post-traumatic stress disorder). We also hope to further our understanding of family stress and expand the idea for a need of mental health services in pediatric oncology. We aim to further understand intervention strategies for domains of family stress, reducing levels of caregiver anxiety, and promoting resilience for caregivers. This is important because these symptoms can affect the quality of life of caregivers and affect their ability to adhere to their children's treatments.

GOLD: Brief Intervention to Reduce Anxiety and Promote Resilience in Families of Youth With Cancer

Brief Intervention to Reduce Anxiety and Promote Resilience in Caregivers of Youth With Cancer

Measurement will be based on the percentage of caregivers who provide consent, and are retained in the program through 1-month follow-up.

Acceptability will be measure by the percentage of caregivers who provide complete data, and who are retained through 1-month follow-up

Stanford University

Psychotropic Drugs

MIND programme for cancer is a manualized acceptance, mindfulness and compassionate-based group intervention for cancer patients. It included 8 weekly group sessions, 2h hours each, run in small groups (ranging from 6 to 12 participants).

Participants in this group also receive cancer treatment as usually performed at the Coimbra University Hospital.

Cancer treatment as usually performed at the Coimbra University Hospital.

Psychotherapeutic programme based on Acceptance, Mindfulness and Compassion for cancer patients Other: Cancer Treatment as Usual

MIND programme for cancer patients

Standard personalized treatment of cancer

This investigation aims to apply and test the acceptability of an acceptance, mindfulness and compassionate-based intervention structured for cancer patients. MIND programme for cancer thus comprises 8 weekly group sessions, lasting 1 and a half hour each, run in small groups at an Oncology Service at the Coimbra's University Hospital. For each week participants have assigned homework (e.g., mindfulness exercises). This programme mainly aims to increase participants' physical and psychosocial quality of life, and attenuate depressed mood and anxiety.

The sample will include diagnosed cancer patients recruited at an Oncology Service at the Coimbra's University Hospital. Patients will be approached by their doctor to assess their level of interest in the investigation. Patients who demonstrate interest will go through a Screening interview conducted by a licensed psychologist that aims explain the structure and arms of the investigation, to collect demographic data, and whether the patient meets the inclusion criteria for the study. Patients who meet the inclusion criteria and demonstrate interest in participating in the study, will sign an informed consent. All ethical requirements for research with humans are guaranteed.

Afterwards, participants will be allocated in two groups (experimental and control group). Both groups will maintain the medical treatment as usual (TAU). Additionally, the experimental group will enroll in the MIND programme for cancer patients, also provided by a licensed psychologist.

Both groups will concurrently complete a protocol of self-report measures and their medical data will be collected by the medical staff of the Hospital.

MIND Programme for Cancer Patients

MIND Programme for Cancer Patients: A Group Intervention Programme Based on Third Wave Psychotherapies

Measured by the World Health Organization Quality of Life questionnaire (WHOQOL-BREF)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pain Related to Head and Neck Cancer (HNC); Implementation and Evaluation of Self-care Measure Due to the Same Illness	NCT03089736	Pain Head and Neck C...	Education Self Care Treatment as us...	18 Years -	Linkoeping University
Psychological Interventions to Prevent Late Effects in Breast Cancer	NCT04518085	Pain, Postopera... Fatigue Breast Cancer	Medical hypnosi... Internet-based ... Mindfulness ses... Treatment as Us...	18 Years - 70 Years	University of Oslo
GOLD: Brief Intervention to Reduce Anxiety and Promote Resilience in Families of Youth With Cancer	NCT05415007	Cancer	GOLD Program Treatment as us...	8 Years - 18 Years	Stanford University
Pain Related to Head and Neck Cancer (HNC); Implementation and Evaluation of Self-care Measure Due to the Same Illness	NCT03089736	Pain Head and Neck C...	Education Self Care Treatment as us...	18 Years -	Linkoeping University
MIND Programme for Cancer Patients	NCT02943174	Cancer	MIND programme ... Treatment as Us...	18 Years - 70 Years	University of Coimbra
Psychological Interventions to Prevent Late Effects in Breast Cancer	NCT04518085	Pain, Postopera... Fatigue Breast Cancer	Medical hypnosi... Internet-based ... Mindfulness ses... Treatment as Us...	18 Years - 70 Years	University of Oslo

Spots Global Cancer Trial Database for treatment as usual (tau)