Quality of Life in Patients With Anal Cancer

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Brief Title

Quality of Life in Patients With Anal Cancer

Official Title

ANCA - A Registry Based Study of Clinical Results and Health Related Quality of Life in Patients After Treatment for Anal Cancer

Brief Summary

      A national study of a three year cohort consisting of all patients diagnosed with anal cancer
      in 2011- 2013 with data retrieval from three national registries: Cancer Registry, Patient
      registry and Cause of Death Registry all within the Swedish Board of Health and Welfare. All
      out- and inpatient visits with diagnoses, admission dates and discharge dates will be
      requested including.

      Patient documentation from the concerned hospitals will be collected and data on the details
      of the treatment collected retrospectively in a standardised fashion using a clinical record
      form.

      Comorbidity will be calculated using data from the Patient Registry using all main and
      co-diagnoses 2 years prior and then at least two years after treatment cessation.

      Detailed questionnaires will be sent out once at 2-3 years and a second time at about 6 years
      after index treatment.
    

Detailed Description

      Squamous cell carcinoma of the anus or "anal cancer" is an uncommon disease in the Western
      world. In Sweden approximately 100 patients are diagnosed each year. Most patients are
      treated by chemotherapy and radiation, but a small subgroup of non-responders and patients
      with recurrent disease undergo abdominoperineal excision with a permanent colostomy. In most
      reports of results these patients have a worse prognosis and a higher risk of local
      recurrence than anal cancer as a group(1, 2), possibly a result of a selection bias. Recently
      the results in a large Nordic cohort were presented, indicating that a further factor
      connected with successful outcome was that the patient was included in a treatment
      protocol(3).

      A small number of patients with very small cancers are operated on primarily. This is
      especially true for anal margin tumours(4). However, for the most part patients will be
      primarily treated with radiotherapy, as their curative treatment.

      In Sweden the treatment has been centralised for many years. The radiotherapy is normally a
      long course therapy with many smaller doses resulting in a high dose of radiation. There are
      well known complications such as skin problems and to some extent chronic radiation effects
      on deeper structures, which can result in functional side effects. If the treatment includes
      an abdominoperineal excision, the effects of a colostomy on quality of life as well as
      functional aspects of this surgical procedure are largely unknown in this group of patients.
      In our research group we have earlier studied large cohorts of patients who have undergone
      abdominoperineal excision for rectal cancer, and also unselected groups of patients with
      rectal cancer, studying both functional aspects and quality of life using detailed
      questionnaires (5, 6). Further we have results on quality of life from a cohort of Swedish
      inhabitants, representing men and women aged 30 to 90 years. The majority of the questions in
      these questionnaires are similar making comparisons possible.

      In other studies within the SSORG network we have used the "Steineck concept" to investigate
      patient experiences of health, functional results and quality of life (7-11). We use specific
      questionnaires with detailed questions about experiences and symptoms asking about severity
      and duration as well as questions on socioeconomic functioning and life style factors (12,
      13). Our experience is that patients are motivated to answer such questionnaires, with a
      compliance at 3 months >90% and at 12 months >85%.
    


Study Type

Observational


Primary Outcome

HRQL in patient's with anal cancer 3 years after diagnosis

Secondary Outcome

 HRQL in patient's with anal cancer 6 years after diagnosis Functional aspects and symptoms

Condition

Anal Cancer


Study Arms / Comparison Groups

 Patients with anal cancer
Description:  All patients with anal cancer during 2011-2013 will be asked to participate

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

300

Start Date

September 2015

Completion Date

December 2023

Primary Completion Date

February 2022

Eligibility Criteria

        Inclusion Criteria:

          -  All patients registered with a diagnosis of anal cancer in either the Patient registry
             or the Cancer Registry during 2011 - 2013.

        Exclusion Criteria:

          -  No informed consent received for participation in the questionnaire part of the study.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Eva Angenete, M.D., Ph.D., , 

Location Countries

Sweden

Location Countries

Sweden

Administrative Informations


NCT ID

NCT02546973

Organization ID

ANCA


Responsible Party

Principal Investigator

Study Sponsor

Sahlgrenska University Hospital, Sweden


Study Sponsor

Eva Angenete, M.D., Ph.D., Principal Investigator, Sahlgrenska University Hospital, Sweden


Verification Date

December 2021