Behaviors and Mental Disorders

All Conditions

Quality of Life

patients who specify their preference for either acupuncture or touch therapy

with no preference, to be randomly allocated to either the acupuncture or touch-therapy subgroup

Acupuncture points will be selected on an individualized and symptom-directed basis, with the incorporation of points shown in clinical research to be effective for specific symptoms

Acupuncture

Touch therapies are to include Reflexology, Shiatsu and Therapeutic Touch

Touch Therapies

Noah Samuels, M.D.

Nathan Cherny, M.D.

The use of complementary and integrative medicine (CIM) among oncology patients is widespread, with a large body of research-based evidence supporting the ability of these therapies to alleviate symptoms related to cancer and its treatment. Organizations such as the American Society for Clinical Oncology and the European Society for Medical Oncology have included CIM modalities in their treatment guidelines, and many of today's leading cancer centers include CIM in their supportive care service. The proposed study will prospectively examine the impact of a CIM treatment program on the symptom burden, quality of life and function of patients undergoing active oncology treatment.

A total of 750 patients will undergo an integrative oncologist (IP) consultation followed by a series of 8 CIM treatments consisting of either acupuncture or touch-related therapies (reflexology, Shiatsu, Tuina, etc.) with the goal of relieving their symptoms. Patients will be allocated to one of the two study treatment arms: the "Patient-Preference Arm", for patients who specify their preference for either acupuncture or touch therapy; and the "Randomized Treatment Arm", for those with no preference, to be randomly allocated to either the acupuncture or touch-therapy subgroup. Patients will be asked to complete the following study questionnaires before and after the treatment regimen: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30); the Edmonton Symptom Assessment System (ESAS); and the Measure Yourself Concerns and Wellbeing (MYCAW) tool. The primary study outcome will be the change in EORTC Global Health-Status / Quality of Life scores, from pre- to post-treatment. Secondary study outcomes will include EORTC QLQ-C30 functional and symptom scales, single items assessing additional symptoms commonly reported by cancer patients, and perceived financial impact of the disease; ESAS severity scores for 10 quality-of life related items; and MYCAW severity scores for the 2 most significant symptoms, as well as post-treatment narratives. Other secondary outcomes to be assessed include the safety of the study treatments (adverse effects); adherence to conventional treatment regimen; and narratives from the patient's informal caregiver (spouse, parent/child, sibling, friend, etc.).

Patient-preference, pragmatic methodology

Integrative Oncology for Patient Symptoms

Examining the Impact of an Integrative Oncology Program on Patient Symptoms and Quality of Life: a Prospective Pragmatic Registry Protocol Study

Change from baseline to the end of the 8-week integrative treatment program

Change from baseline and 8-week assessment to 16 week follow-up

Change in severity scores for 10 quality-of life related items

Change in severity scores for the 2 most significant symptoms, as well as post-treatment narratives

Any reported adverse events taking place during the study period which are considered to have possibly/probably resulted from the CIM intervention

Adherence to oncology treatment to be measured using the Relative Dose Intensity (RDI) calculation

Narratives from the patient's informal caregiver (spouse, parent/child, sibling, friend, etc.).

Shaare Zedek Medical Center

Director, Center for Integrative Complementary Medicine

Neoplasms

Digestive System Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

All Drugs and Chemicals

Hormones

Women with rectal cancer treated with preoperative radiotherapy (RT) and surgery.

Women with rectal cancer treated with surgery alone (no RT).

Preoperative radiotherapy (RT) was administered as either short course (5Gy x5) or long-course (2Gy x25 or 1.8 Gy x25 with or without 3 fractions of boost to the primary tumor and radiologically malignant lymph nodes) treatment with or without concomitant or sequential chemotherapy. Oncological treatment was decided at a multidisciplinary team conference.

Preoperative radiotherapy

Anna Martling

Preoperative radiotherapy (RT) and pelvic surgery is recommended to many patients with rectal cancer. For women there are theoretical reasons to believe that the treatment may affect hormone levels, sexual function and wellbeing. To address these questions a longitudinal observational study was initiated where androgen levels and sexual function were assessed before treatment (baseline) and during a follow-up period of two years.

Women with rectal cancer stage I to III planned for abdominal surgery was included in the study. Women treated with preoperative RT were assigned to the exposed group and women treated with surgery alone were assigned to the unexposed group.

142 participants were enrolled at five outpatient rectal cancer centres in Sweden between 2008 and 2013. Patient data, fasting venous blood samples and questionnaires regarding sexual function and well-being were collected at a baseline visit before start of oncologic treatment, 1 year after surgery and 2 years after surgery (only questionnaires). Women treated with preoperative RT for rectal cancer had an additional venous blood sample taken the day before surgery.

Changes in serum levels of testosterone and sexual function during follow-up was assessed and compared between exposed and unexposed participants.

Sexual Function and Wellbeing in Females With Rectal Cancer

Sexual Function and Wellbeing in Females Diagnosed With Rectal Cancer

Fasting venous blood samples were collected at baseline visit (prior to oncological treatment) and 1 year follow-up. Participants treated with preoperative radiotherapy (RT) had an additional blood sample taken the day before surgery. Serum testosterone levels (T) were measured with liquid chromatography-mass spectrometry using the LC-MS/MS Quattro Premier Xevo TQ MS (Waters Corporation, Milford, MA, USA). The total coefficients of variation (CVtot) were 7% at 2.8 nmol/L and 6% at 15 nmol/L.

Sexual function was assessed using the Female Sexual Function Index (FSFI). The FSFI questionnaire is a 19-item multiple-choice, self-assessment tool validated for use in the general population as well as for patients with cancer. It covers six domains of sexual function in women; desire (2 items), arousal (4 items), lubrication (4 items), orgasm (3 items), satisfaction (3 items) and pain (3 items). Items scores between 0 or 1 to 5, with lower scores indicating worse function. A total FSFI score can be calculated when all items are completed. Minimal total score is 4 points and maximal score is 95 points, with lower scores indicating worse function. A total FSFI score of less than 26.55 points was used to define overall sexual dysfunction.

Swedish Cancer Society

Karolinska Institutet

Professor, Senior Consultant Surgeon

Preoperative RT

No Preoperative RT

Preoperative Radiotherapy

No Preoperative Radiotherapy

Total

Age, Continuous

Sex: Female, Male

Missing

ASA score is a classification system for physical status ranging from scores I to VI with higher scores indicating worse physical status. Definitions of scores: I = Normal healthy person, II = A patient with mild systemic disease, III = A patient with severe systemic disease.

ASA score

0-4 cm

5-10 cm

11-15 cm

Tumour distance from anal verge

Short course (5Gy x5)

Long course (2 Gy x25 or 1.8 x28)

No RT

Type of preoperative RT

Anterior resection

Abdominal excision

No abdominal surgery

Type of Surgery

Hysterectomy

Unilateral/bilateral oophorectomy

Partial vaginal resection

No resection

Includes resections before study inclusion and as part of rectal cancer surgery.

Resection of gynaecological organs

Pathological tumour stage is determined by examining tissue removed during surgery. Staging is based on the American Joint Committee on Cancer (AJCC) TNM system, with T being the extent of the tumour, N spread to nearby lymph nodes and M spread to distant sites. This is summarised into a score ranging from 0 to IV, with 0 being very early cancer and higher numbers indicating more advanced cancer.

Pathological tumour stage

Neoadjuvant chemotherapy

Adjuvant chemotherapy

Professor Anna Martling

The change in serum testosterone levels between baseline and 1 year was assessed using longitudinal regression analysis (GEE).

Baseline

After RT/before surgery

1 year after surgery

17 of the included 142 participants were excluded due to history of oophorectomy, resulting in 125 participants analysed. Participants in the group "No preoperative radiotherapy" had no blood samples taken at the time point "After RT/before surgery".

Change in Serum Testosterone Levels Between Baseline and 1 Year After Surgery.

The association between mean change in total FSFI score and preoperative RT was assessed using longitudinal regression analysis (GEE), using "no preoperative radiotherapy" as the reference group.

2 years after surgery

Of the 142 participants included in the study, 3 were excluded due to not answering FSFI questionnaires at any timepoint. Total FSFI scores were only calculated for available questionnaires without missing items.

Change in Sexual Function (Total FSFI Scores) Between Baseline and 2 Years Follow-up.

Overall Study

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Wounds and Injuries

Syndrome

Prostatic Neoplasms

Radiation Injuries

Gynecological Cancer survivors with treatment induced survivorship syndroms treated pelvic radiotherapy at

1. Radiumhemmat, Karolinska University Hospital and
2. Jubileumskliniken at Sahlgrenska University Hospital in Sweden.

Prostate Cancer survivors treated with radiotherapy for localized prostate cancer at Sahlgrenska University Hospital, Gothenburg, Sweden

Gynecological Cancer survivors with treatment induced survivorship syndroms treated pelvic radiotherapy

Radiotherapy

Gunnar Steineck

The investigators plan to investigate the consequences of late effects (radiation-induced survivorship syndromes) after radiotherapy in Gynecological and Prostate cancer survivors on return to work (Yes/No) and if RTW happened then time to RTW.

In addition, whether general health, type of work (occupation), work environment factors, individual factors (lifestyle, socioeconomic status etc.), contribute to the adverse late effects of radiotherapy and these Gynecological cancer survivors have a higher risk for disability pension/long term sickness absence (NOT Return to work).

Occurrence of cancer diagnoses are rising, and both disease and treatments are aggressive. Due to advancement in medical technology, improved therapy and/or early detection the overall survival rates are also improving.

Some of the most common cancer types, such as breast cancer, prostate cancer, cervical cancer, and colorectal cancer have high cure rates when detected early and treated according to best practices. Many of these cancer survivors are of working age and are likely to return to work. Women who survive cervical cancer and men who survive testicular cancer typically have three to four decades left in working life.

However, return to work (RTW) among cancer survivors may not be similar to RTW among long-term sickness absentees due to other diagnoses. Cancer is a life threatening disease and cancer diagnose is a life changing event. The emotional shock after the cancer diagnosis may be associated with low psychological well-being even two years after prostate cancer surgery.

The successful cancer treatment concludes with the lifelong consequences of surgery, irradiation, cytotoxic chemotherapy, biological anticancer substances or other drugs in the treatment. The ionizing radiation that eliminates malignant cells may trigger long-lasting pathophysiological processes in the normal tissue and affect the health of the survivors with lifelong treatment-induced survivorship diseases. In a recent study, Steineck et al, identified five radiation-induced survivorship syndromes affecting bowel health in a cohort of gynecological cancer; urgency syndrome (30%), leakage syndrome (26%), excessive gas discharge(15%), excessive mucus discharge (16%) and blood discharge (10%).

There is a lack of knowledge about how these side effects of cancer treatment affect the degree of work ability and return to work. Clinical experience suggests that many cancer survivors have reduced work ability. There is a need for scientific studies that shed light on the side effects of cancer treatment and their relation to work ability.

Gyaecological cancer survivors Prostate cancer survivors

Return to Work Among Cancer Survivors With Treatment-induced Survivorship Syndromes

Information on Sickness absence for more than 14 days was obtained from the official registries in Sweden.

Sickness absence (more than 14 days) until the survivor returned to work. Also obtained from the official registries in Sweden.

Vastra Gotaland Region

Sahlgrenska University Hospital, Sweden

Professor / Senior consultant

Anxiety Disorders

Depression

Depressive Disorder

Behavioral Symptoms

The intervention includes cognitive behavioral therapy management strategies for health-related stress in the form of animated videos, interactive activities, and written content. The intervention will be delivered via an online application over an 7-week period. Intervention participants will also complete four assessments: baseline (at the beginning of the research study), post-intervention (7 weeks after baseline), a 6-month follow-up, and a 12-month follow up.

The control application will provide links to helpful resources for patients with cancer, such as the contact information for cancer support services at Northwestern University and the University of Miami, and the link to the National Cancer Institute website, and the American Cancer Society website. Control participants will also complete four assessments: baseline (at the beginning of the research study), post-intervention (7 weeks after baseline), a 6-month follow-up, and a 12-month follow up.

My Wellbeing Guide

Diana Buitrago, MPH

Betina Yanez, PhD

Diana Buitrago

The purpose of this study is to examine the implementation and effectiveness of the psychosocial eHealth intervention, My Wellbeing Guide, on the proposed primary outcome, depressive symptoms, in patients diagnosed with cancer who receive care at Northwestern Medicine and the University of Miami Health System.

The intervention includes cognitive behavioral therapy management strategies for health-related stress in the form of animated videos, interactive activities, and written content. The intervention will be delivered via an online application over an 7-week period. Intervention participants will also complete four assessments: baseline (at the beginning of the research study), post-intervention (7 weeks after baseline), a 6-month follow-up, and a 12-month follow up.

Participants are randomized into either an intervention application (described above) or a control application (which will provide links to helpful resources for patients with cancer, such as the contact information for cancer support services at Northwestern University and the University of Miami, and the link to the National Cancer Institute website, and the American Cancer Society website.) Control participants will also complete four assessments: baseline (at the beginning of the research study), post-intervention (7 weeks after baseline), a 6-month follow-up, and a 12-month follow up.

Depression is one of the most common psychological comorbidities experienced throughout the cancer continuum. Elevated depressive symptoms in oncology patients is a major concern as unmanaged depressive symptoms in cancer patients is associated with poor health-related quality of life (HRQoL), poor adherence to cancer treatments, delayed return to work and baseline function, greater emergency department visits, and higher all-cause mortality. Behavioral interventions for the management of depression are efficacious, but scalability and implementation of these evidence-based interventions in oncology is limited. Health information technologies (HIT) provide an ideal opportunity to expedite the administration, scoring, and interpretation of depression screening with well-validated, brief and precise measurement tools that can capture actionable data to screen for depression, and deliver pragmatic and scalable evidence-based behavioral interventions that are proven to reduce depressive symptomatology across various other populations.

The study takes place across two distinct health systems in two major metropolitan areas-Chicago and Miami (Northwestern Medicine and University of Miami Health System). While across the two health systems (NM and UHealth), patients already receive EHR-delivered assessments that are linked to EPIC and real-time alerts sent to supportive oncology for patients with moderately to severely elevated symptoms, a lacking component is the integration of an evidence-based, HIT management program for elevated depressive symptoms.

The investigators will evaluate the effectiveness and the implementation of an evidence-based HIT behavioral treatment for cancer patients with elevated depressive symptoms. This HIT treatment combines systematic, electronic health record-integrated screening for depressive symptoms with an individually-tailored HIT interventions to address gaps in the treatment of depression among cancer patients. The investigators' specific aims are as follows:

Aim 1a. To further develop and refine My Wellbeing Guide, a web-based platform to optimize management of elevated depressive symptoms in ambulatory oncology in two large health systems.

Aim 1b. To establish the effectiveness of My Wellbeing Guide on depressive symptoms (i.e., primary outcome) and anxiety, HRQoL, and health services utilization (i.e. secondary outcomes), and putative mechanisms of action/mediators (e.g., self -efficacy) of My Wellbeing Guide on study outcomes compared to usual care.

Aim 1c. To evaluate the process of implementing My Wellbeing Guide and its impact on patient and system-level outcomes through electronic health record (EHR) extractions of Aim 1b patients, and through clinician, and hospital administrator interviews.

Aim 2. To identify facilitators and barriers to wide-scale implementation and expansion of My Wellbeing Guide through interviews and focus groups with stakeholders (clinicians, hospital administrators, and patients who participated in My Wellbeing Guide).

My Wellbeing Guide: A Novel Tool for Managing Stress and Improving Quality of Life

My Wellbeing Guide, Technology Facilitated Behavioral Intervention for Depression Among Diverse Patients in Ambulatory Oncology

The Patient-Reported Outcomes Measurement Information System (PROMIS) Depression questionnaire is a previously validated patient-report measure of depressive symptoms in the last seven days. Scores generally range from 20 - 80, with higher scores indicating a patient is reporting more severe levels of depression.

The Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety questionnaire is a previously validated patient-report measure of symptoms of anxiety in the last seven days. Scores generally range from 20 - 80, with higher scores indicating a patient is reporting more severe levels of anxiety.

The Functional Assessment of Cancer Therapy - General - 7 item version (FACT-G7) has been used extensively to measure Health Related Quality of Life (HRQoL). The FACT-G7assesses participant's wellbeing in physical, emotional, social, and functional concerns in the last seven days using a five-point response scale. Scores range from 0-28, with higher scores indicating better quality of life.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Integrative Oncology for Patient Symptoms	NCT04940780	Oncologic Compl... Symptoms and Si...	Acupuncture Touch Therapies	18 Years -	Shaare Zedek Medical Center
Integrative Oncology for Patient Symptoms	NCT04940780	Oncologic Compl... Symptoms and Si...	Acupuncture Touch Therapies	18 Years -	Shaare Zedek Medical Center
Sexual Function and Wellbeing in Females With Rectal Cancer	NCT01216189	Rectal Cancer	Preoperative ra...	18 Years -	Karolinska Institutet
Return to Work Among Cancer Survivors With Treatment-induced Survivorship Syndromes	NCT03961217	Gynecologic Can... Prostate Cancer Radiation Toxic... Malignancy Radiotherapy Si... Radiation Injur... Cancer Survivor... Radiation Syndr...	Radiotherapy	25 Years - 60 Years	Sahlgrenska University Hospital, Sweden
My Wellbeing Guide: A Novel Tool for Managing Stress and Improving Quality of Life	NCT05369429	Cancer Anxiety Depressive Symp...	My Wellbeing Gu...	18 Years -	Northwestern University
Sexual Function and Wellbeing in Females With Rectal Cancer	NCT01216189	Rectal Cancer	Preoperative ra...	18 Years -	Karolinska Institutet
My Wellbeing Guide: A Novel Tool for Managing Stress and Improving Quality of Life	NCT05369429	Cancer Anxiety Depressive Symp...	My Wellbeing Gu...	18 Years -	Northwestern University

Spots Global Cancer Trial Database for wellbeing

Every month we try and update this database with for wellbeing cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for wellbeing

Every month we try and update this database with for wellbeing cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for wellbeing cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.