Neoplasms

Symptoms and General Pathology

All Conditions

Behaviors and Mental Disorders

Occupational Diseases

Neoplasm Metastasis

Fatigue

Burnout, Psychological

Burnout, Professional

Compassion Fatigue

Neoplastic Processes

Stress, Psychological

Behavioral Symptoms

Occupational Stress

Mental Fatigue

Participants in the intervention will participate in the 6-week mindfulness self-compassion course delivered online.

This course is designed to reduce burnout and compassion fatigue among specialist rehabilitation providers. Course materials are adapted from the Center for Mindful Self-Compassion (CMSC).

Mindfulness Self-Compassion Course

Robert Simpson, Md, PhD

The goal of this clinical trial is to explore the impact of an online compassion-based intervention on burnout among specialist rehabilitation providers. Post-intervention interviews aim to gather information on: burnout and compassion, experiences with the intervention, barriers and facilitators to taking part, and suggestions for improving online course delivery.

Burnout threatens the sustainability of compassionate care in rehabilitation. This project explores the impact of an online compassion-based intervention on burnout among specialist inpatient rehabilitation healthcare providers. Thirty specialist rehabilitation healthcare providers will be recruited to take part. The online intervention will include six weekly live one-hour sessions. Healthcare provider socio-demographic, practice, and wellness measures will be collected at baseline, post-course, and three months later. Qualitative interviews will be used to explore participant views on burnout and compassion, experiences with the intervention, barriers and facilitators to taking part, and suggestions for improving online course delivery. Up to two instructors and support persons will be invited to participate in qualitative interviews to explore their views for improving online course delivery.

A Mindful Self-compassion Based Intervention for Specialist Rehabilitation Providers

Mindful Self-compassion, Compassion Fatigue, Secondary Traumatic Stress, and Burnout Among Specialist Rehabilitation Providers - a Mixed Methods Study Protocol

Measures the positive and negative effects of one's compassion for those that they help rehabilitate.

Measure's ones tendencies for receiving and providing relational compassion.

Measures how one typically acts towards themselves in difficult times.

Measures the different ways that people may think about their lives.

Measures one's tendencies to engage in mindfulness practices.

Measures one's thoughts and feelings pertaining to stress.

Sunnybrook Health Sciences Centre

Physiatrist and Associate Scientist

Skin and Connective Tissue Diseases

Substance Related Disorders

Breast Neoplasms

Cognitive Dysfunction

Chemotherapy-Related Cognitive Impairment

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Quality of Life

Online games designed to target specific cognitive skills such as attention, perception, or inhibition). Activities' difficulty will be automatically adjusted accordingly to each participant's performance, always demanding a maximum cognitive effort.

Online painting and artistic games designed not to target the specific cognitive skills at test. Activities' duration will match those of the experimental group, and its difficulty will be constant through the intervention.

Online gamified activities designed to stimulate cognitive functions (specifically executive function) will be carried out through a mobile application or web browser. Performance feedback will be shown after each activity.

Personalized cognitive stimulation

Non-therapeutic online games based on artistic tasks designed to not train the specific cognitive abilities at test. The time of each session will match that of the experimental group. Performance feedback will be shown after each game.

Sham cognitive stimulation

Jon A Duñabeitia

Jose L Tapia

Maria T Taberner

Athanasious Pouptsis

David Collado

Martín Núñez

The present study aims to establish a non-pharmacological alternative in alleviating cognitive deterioration derived from undergoing chemotherapy treatment. Thus, the effectiveness of a personalized and computerized cognitive stimulation program in breast cancer survivors is assessed.

A phase I/II/III clinical trial is proposed in which the first two phases will serve to evaluate the safety of the intervention and the maximum tolerated time of computerized cognitive training per session in the absence of adverse effects. The third phase will consist of a double-blind randomized controlled trial where the effectiveness of the personalized and self-administered computerized cognitive stimulation program will be evaluated.

Phase I. Based on a dose-escalation 3+3 design, experienced fatigue or adverse effects will be measured after succeeding 15 minutes cognitive stimulation training blocks. The training dose will be set to a block before extreme fatigue or notable adverse effect has been reported by two or more participants. A trained psychologist will supervise the process.

Phase II. To evaluate the effectiveness of the intervention, 20 participants will undertake an interspersed training day and evaluation day through 15 consecutive days. In this way, a total of 8 evaluation sessions (day 1, 3, 5, 7, 9, 11, 13, and 15) and 7 cognitive stimulation sessions (day 2, 4, 6, 8, 10, 12, and 14) will be carried out. A trained psychologist will supervise every step of the process.

Phase III. An 8-week personalized and computerized cognitive stimulation program will be established, where the training time per session will be as determined on phase I. 120 participants will be randomized 1:1 ratio to an intervention or active control group. All participants will undertake a pre and post-test, with a total of 40 training sessions (Monday to Friday) during 8 weeks. Although this phase is set to be an online home-based stage, the responsible psychologist will be monitoring participants' performance and will periodically contact participants via telephone.

A home-based intervention will be set through the CogniFit® online platform. Participants will access remotely from home using a personal computer or smart device. The cognitive stimulation program will be held for 5 consecutive days (Monday to Friday) for 8 weeks, completing a total of 40 training sessions. Researchers will supervise the participant's performance daily and will periodically contact participants via telephone.

The intervention platform will randomly assign participants in a 1:1 ratio to one out of two groups (control/experimental), so both participants and researchers are blinded.

Activities presented to the experimental group will target specific cognitive domains (mainly executive functions) and will be automatically adjusted in difficulty and requirement according to each participant's performance. Thus, maximum cognitive effort is always required.

Activities presented to the active control group will target orthogonal unrelated cognitive domains (i.e. artistic cognitive processes) and will be of constant difficulty.

Since the study population is breast cancer survivors, and considering its epidemiology, investigators will restrict participants to females.

Cognitive Stimulation and Chemobrain. An Innovative Intervention for Cancer Survivors

Cognitive Stimulation Intervention Program for Cancer Survivors and Its Benefit on Cognitive Performance and Quality of Life

The data protection policy of the public health system of the Spanish government does not allow researchers to share individual participant data.

The mini-MAC is a validated 29-item self-rated questionnaire that examines five cancer-specific coping strategies: fighting spirit, helplessness, anxious preoccupation, cognitive avoidance, and fatalism. Each item is scored using a 4-point Likert scale. Higher scores on each subscale mean greater use of that strategy.

The CAB-CF is an online neuropsychological assessment battery that evaluates a total of 23 cognitive skills, grouped into 5 cognitive domains (attention, memory, coordination, perception, and reasoning). Each cognitive skill is scored from 0 to 800. The cognitive domain score is calculated by averaging the scores of the cognitive skills that comprise it. Higher scores mean better cognitive performance.

The FACT-COG is a 37 item self-report questionnaire that assesses patients' perception of their cognitive abilities, functionality, and quality of life. Each item is scored using a 5-point Likert scale. Higher scores indicate less perceived cognitive impairment.

The STAI is a validated self-report that assesses anxiety that measures both trait and state anxiety. Each item is scored using a 4-point Likert scale. Possible scores range from 0 (no anxiety) to 60 (severe anxiety), for each category.

The BDI-II is a validated 21-item self-report inventory designed to measure the frequency and severity of depressive symptoms. Scores range from 0 (no depressive symptoms) to 63 (severe depression).

The BFI is a 9-items instrument designed to assess the severity and impact of cancer-related fatigue. For the three items that assess fatigue severity, scores range from 0 (no fatigue) to 10 (the worst fatigue you can imagine). For the six items that assess how fatigue interferes with daily life, scores range from 0 (does not interfere) to 10 (interferes completely).

The WHOQOL-BREF is a 26-question questionnaire designed to measure the quality of life. It has two questions concerning the general satisfaction with health, and the remaining 24 questions are grouped in four areas: physical health, psychological health, social relations, and environment. Scores for each domain range from 0 (poor perceived quality of life) to 100 (greater perceived quality of life)

The C-SSRS is a questionnaire designed to assess the existence of thoughts, desires or behaviors related to suicidal ideation, assessing a total of ten categories (wish to be dead; non-specific active suicidal thoughts; active suicidal ideation with any methods without intent to act; active suicidal ideation with some intent to act, without a specific plan; active suicidal Ideation with a specific plan and intent; preparatory acts or behavior; aborted attempt; interrupted attempt; actual attempt; completed suicide. The questionnaire can be administered as a self-report, with additional open-ended follow-up questions to provide more information. Scoring refers to the presence or absence of each of the 10 categories, provided by the dichotomous responses (Yes/No).

Hospital de la Ribera

Universidad Antonio de Nebrija

Director

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

The participants in the support group will receive 6 weekly online intervention sessions with a professional facilitator. In addition participants will be asked to complete relationship-enhancement exercises and readings in between sessions.

Participants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks).

Participants will be asked to complete questionnaires at three time points: 1)week 1 2) week 7, and 3) week 13.

The participants in the experimental group will receive 6 weekly online intervention sessions with a professional facilitator. In addition participants will be asked to complete relationship-enhancement exercises and readings in between sessions.

In the experimental group, participants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks).

In the waitlist group, participants will not participate in the support group. Participants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks).

Couples Prostate Cancer Support Group

Deborah L McLeod, R.N., Ph.D.

Deborah L McLeod

Richard J Wassersug, Ph.D.

Karen Fergus, Ph.D., C. Psych.

John Robinson, Ph.D., C. Psych.

John Oliffe, R.N, Ph.D.

Background: Prostate cancer (PCa) is the most common cancer for men. When treated early enough it is typically curable. However, common treatments, such as radical prostatectomy and radiation therapy, often result in significant negative outcomes with regard to sexual, psychological and social function. Both men and partners have identified the need for more information and support to address sexual health concerns after treatment. However, very few sexual rehabilitation interventions have been developed and rigorously assessed.

Purpose: The investigators propose to develop and pilot test a new program to meet the sexual health needs of men with PCa and their partners using an online, professionally facilitated education/support program. The goals of the program are to improve sexual function, intimacy and mood for men and their partners after treatment for localized PCa. The program will be offered through Cancer Chat Canada, an existing and well-tested Canadian platform for professionally facilitated support group programs.

What Participants Can Expect: A total of 24 men and their female partners (48 individuals) will be recruited and assigned to one of two groups. The first group will participate in the program immediately; the second group will be offered the program after a 5-month delay. The decision about which group will start immediately and which later will be made randomly (by chance). Both groups of men and partners will be asked to complete questionnaires three times and, at the end of the program, to provide the researchers feedback about how satisfied they were with the program, the changes they made, things they learned as a result of the program, and suggestions for improving the program. Participants must have access to a computer, an Internet connection and be willing to attend online, chat room meetings each week for 1.5 hours for 6 weeks.

Implications: Sexual rehabilitation is a high need for men affected by PCa, but is difficult to access. The investigators hope to improve access to sexual health care through this study.

A Feasibility Study of an Online Intervention for Sexual Rehabilitation in Prostate Cancer

This tool assesses psychological distress across 6 domains: fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment.

Canada: Beatrice Hunter Cancer Research Institute

Nova Scotia Health Authority

Breast Diseases

Skin Diseases

A guided internet-delivered ACT intervention to improve psychosocial outcomes in BCP diagnosed in the past two years.

A guided internet-delivered ACT intervention to improve psychosocial outcomes in BCP diagnosed in the past two years

iACT-BC: Oncovox

Silvia M Nicolescu, Ms

Background: Online interventions can be a fast, cost-efficient, and convenient medium for providing breast cancer patients (BCP) with access to evidence-based interventions that address their emotional needs. As true as that may be, online interventions are still a novel research area that struggles in implementation.

Objectives: This study aims to determine the acceptability, feasibility, and efficacy of Oncovox, an iACT-BC, a guided internet delivered ACT intervention designed to improve psychosocial outcomes in BCP diagnosed within the last two years when compared to treatment as usual. The primary outcomes in this study are health related quality of life, behavioural activation, symptom interference and reward observation. The secondary outcomes are psychosocial distress, anxiety and depression and psychological flexibility.

Methods: A two-arm, parallel, open label, waiting list randomised controlled trial will investigate the effectiveness, feasibility, and acceptability of Oncovox.

Expected results: It is anticipated that Oncovox will show to be effective, feasible and acceptable programme in improving health related quality of life, behavioural activation, symptom interference, reward observation, psychological distress, anxiety, depression, and psychological flexibility in BCP diagnosed in the last two years, as opposing to a waiting list control under treatment as usual.

An exploratory moderator analysis will be employed to the assess the significance of Time x Group as well as Time x Group x Surgery type interactions for all outcome and process variables. A mediation analysis to assess the effect of psychological flexibility on the outcomes will also be applied.

The results of this research will be published in accordance with CONSORT 2010 and CONSORT-EHEALTH guidelines and should be available for publication in September 2022.

A Guided Online Intervention to Improve Quality of Life in Breast Cancer Patients - a Randomised Clinical Trial

Oncovox - An Acceptance and Commitment Therapy Guided Online Intervention to Improve Quality of Life in Breast Cancer Patients: a Randomised Clinical Trial

Attitudes towards internet interventions survey (ATTIS)

Attitudes towards internet interventions survey (ATTIS)

A a 37-item instrument designed to measure five domains of HRQOL in breast cancer patients: Physical, social, emotional, functional well-being as well as a breast-cancer subscale (BCS).

Assessing the appetitive-motivational system that is activated by reward consumption and conditioned signals of reward or non-punishment, triggering approach behaviour.

Severity of symptoms experienced by patients with cancer and the interference with daily living caused by these symptoms.

Reports on quantity and availability of reinforcement received by patient from environment

a multifactorial unpleasant experience of a psychological (i.e., cognitive, behavioral, emotional), social, spiritual and/or physical nature that may interfere with the ability to cope effectively with cancer, its physical symptoms, and its treatment.

Measures anxiety and depression in a general medical population of patients

Scale used to assess psychological inflexibility.

Babes-Bolyai University

Phd. Candidate

Nervous System Diseases

Rare Diseases

Peripheral Nervous System Diseases

Pain

Neuromuscular Diseases

Chronic Graft Versus Host Disease

The experimental condition includes an online psychological intervention with therapist email guidance based on Acceptance \& Commitment Therapy (ACT). ACT is a form of Cognitive Behavioral Therapy, which focuses on acceptance of chronic pain in order to be able to perform valuable activities, instead of attempts of avoidance and controlling (Hayes et al., 2012). The main goal of ACT is increasing psychological flexibility, which includes the ability to act effectively according to personal values, with pain. ACT can thereby play a role in creating more realistic expectations regarding expectations of future pain relief. The intervention can be worked through in the participant's own living environment. It consists of 6 modules which can be worked through in 8 weeks.

The control condition includes a waiting list group that can receive treatment-as-usual. Participants are placed on a waiting list and receive the online psychological ACT intervention without email guidance directly after the first follow-up measurement. Participants placed on the waiting list will not receive the ACT intervention immediately. Participants do have the opportunity to access treatment as usual (TAU). Directly after the first, 3-month follow-up measurement these participants receive the opportunity to follow the intervention without email guidance by a therapist.

The first module includes psychoeducation on neuropathic pain and CIPN (Table 1). Participants acquaintance themselves with intervention goals and mindfulness exercises central to ACT. In subsequent modules, participants learn about the aversive effects of pain avoidance, gain insight into their personal values, and work on pain acceptance. Participants exercise to recognize unhelpful thoughts about their pain and learn the difference between the subjective (judging) and objective self, and think about concrete actions to prevent relapse. The intervention primarily consists of text and experiential exercises, complemented with illustrations, metaphors and audio (mp3) files. Additional functionalities may be an outline of experiences by other CIPN patients and/or the ability to keep a diary. Participants in the experimental condition will receive therapist guidance.

Online intervention

Daniëlle L. van de Graaf, MSc

Floortje Mols, PhD

Daniëlle van de Graaf, MSc

Rationale: An average of 30% of adult cancer survivors suffers from chemotherapy-induced peripheral neuropathy (CIPN) ≥ 6 months after completion of chemotherapy, and their quality of life (QoL) is strongly affected due to these symptoms. Treatment options are limited.

Objective: The goal of this study is to examine the effectiveness of an online psychological intervention based on Acceptance and Commitment Therapy (ACT) in a Randomized Controlled Trial (RCT) and compared to a treatment-as-usual control condition (TAU). We aim to improve pain interference in cancer survivors with chronic painful CIPN (present for at least 3 months) in the curative disease phase who were treated with chemotherapy treatment at least 6 months ago (irrespective of disease site).

Study design: It concerns a test of effectiveness of the ACT intervention in an RCT on quality of life. In total, 146 participants will be randomly allocated to one of two groups: the online ACT intervention with therapist email guidance or a control condition that receives treatment-as-usual. Patients in the control condition can follow the online ACT intervention directly after the 3 month-follow up measurement. Self-reported questionnaires will be conducted at baseline, after the intervention, and at 3- and 6-month follow-up. Additionally, interviews will be executed with a subgroup of interested patients afterwards, to explore intervention effects more in-depth. Participants will be sampled via various patient organizations, oncologists, and advertisements distributed via the PROFILES-registry that contains ongoing research projects on CIPN. Data will be collected online via the PROFILES-registry.

Study population: The population consists of adult cancer survivors in the curative disease phase suffering from painful CIPN for at least 3 months and who received chemotherapy treatment 6 or more months ago.

Intervention: An online ACT intervention was developed in the first phase of the QLIPP-CIPN study. In this study phase insights into daily limitations and quality of life of the patient population were gained, which served as the basis of the patient-centered development of the online ACT intervention following the CeHRes roadmap for participatory eHealth design. The intervention includes an 8-week self-management course containing 6 modules regarding psycho-education and ACT- processes. By means of text and exercises people learn to carry out value-oriented goals in daily life with pain. To do this, they learn new ways of coping with pain, including reducing pain avoidance and increasing pain acceptance. Additionally, participants will receive email guidance.

Main study parameters/endpoint: Pain interference in daily life using subscale Interference of the Multidimensional Pain Inventory (MPI). This scale focuses on a psychosocial aspect of chronic pain, specifically the interference with functioning in, for example, work, homework chores, recreational and social activities due to pain.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participation is not expected to have any risks. Participants can quit the study at any moment and will not be excluded based on medication use or other current treatment for CIPN. If participants regress during the intervention and need new chemotherapy treatment, they can choose if they will continue or not. Participants do need to invest time to follow the intervention, which takes around 2 hours per week. Furthermore, it might be confronting to work on pain acceptance for participants. Benefits of participation are foremost a possible improvement in pain interference and reductions in pain and CIPN symptoms.

Effectiveness of Online ACT for Pain Interference in Cancer Survivors With Chronic Painful CIPN

Patient-centered Development and Effectiveness of Online Acceptance and Commitment Therapy for Pain Interference in Cancer Survivors With Persistent Painful Chemotherapy-induced Neuropathy

PROFILES data is freely available (FAIR principles) for non-commercial scientific research trough www.profilesregistry.nl.

Qualitative data on intervention effects and satisfaction will be collected by means of interviews with some participants after completion of the intervention

Multidimensional Pain Inventory - Dutch Language Version (MPI-DLV). Subscale Interference. Minimum = 0, maximum = 60. Higher score means worse outcome.

European Organization for Research and Treatment of Cancer Quality of Life Questionnaires Core-30 item (EORTC QLQ-C30). Minimum = 30, maximum = 126. Higher score means better outcome.

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN20 (EORTC QLQ-CIPN20). Minimum = 0, maximum = 60. Higher score means worse outcome.

Numeric Rating Scale (NRS-11). Minimum = 0, maximum = 20. Higher score means worse outcome.

Pain Catastrophizing Scale (PCS). Minimum = 0, maximum = 65. Higher score means worse outcome.

Hospital Anxiety and Depression Scale (HADS). Minimum = 0, maximum = 56. Higher score means worse outcome.

Psychological Inflexibility in Pain Scale (PIPS). Minimum = 0, maximum = 84. Higher score means worse outcome (higher score means more inflexibility).

Freiburg Mindfulness Inventory (FMI). Minimum = 0, maximum = 56. Higher score means better outcome.

Engaged Living Scale (ELS). Minimum = 0, maximum = 80. Higher score means better outcome.

Questions:

* During the past few weeks, how many hours did you spend on average per week working on the online course?
* On average, how many days per week did you do mindfulness exercises during the past few weeks?
* On the days you practiced mindfulness: On average, how many minutes did you spend practicing?
* How do you rate the quality of the online training you received?
* Did you receive the kind of help you were hoping to receive?
* To what extent did the online training meet your needs?
* Suppose one of your acquaintances needed the same help, would you recommend the online training?
* How satisfied are you with the amount of help you received?
* Did the online training help you cope better with your problems?
* Overall, how satisfied are you with the online training you received?
* Would you do the online training again if you needed to?
* What grade would you give the online training?

Adherence will be based on technical data obtained from Karify's online environment. The following information will be used for this purpose.

* Sent messages: the moment when a message is sent to the supervisor.
* Given feedback: the moment when feedback is given on a specific assignment.
* Significant moment: first_viewed: the moment when an assignment is viewed for the first time.
* Significant moment: finished: the moment when an assignment is handed in for the first time.

This will possibly be combined with the number of hours spent on intervention (self-reported), as described under 'intervention evaluation'.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Mindful Self-compassion Based Intervention for Specialist Rehabilitation Providers	NCT05997082	Burnout, Profes... Compassion Fati... Secondary Traum...	Mindfulness Sel...	18 Years -	Sunnybrook Health Sciences Centre
Cognitive Stimulation and Chemobrain. An Innovative Intervention for Cancer Survivors	NCT05409248	Breast Cancer Cognitive Decli...	Personalized co... Sham cognitive ...	18 Years -	Universidad Antonio de Nebrija
A Feasibility Study of an Online Intervention for Sexual Rehabilitation in Prostate Cancer	NCT01716702	Prostate Cancer	Couples Prostat...	-	Nova Scotia Health Authority
A Guided Online Intervention to Improve Quality of Life in Breast Cancer Patients - a Randomised Clinical Trial	NCT05161312	Cancer, Breast Quality of Life Distress, Emoti...	iACT-BC: Oncovo...	18 Years - 80 Years	Babes-Bolyai University
Effectiveness of Online ACT for Pain Interference in Cancer Survivors With Chronic Painful CIPN	NCT05371158	Chemotherapy-in... Cancer Survivor...	Online interven...	18 Years -	Tilburg University

Spots Global Cancer Trial Database for online intervention